Make your own free website on Tripod.com
Lung Cancer Help
Treatment.Medications.ClinicalTrials
Home | Treatment.Medications.ClinicalTrials | My Special Wish | Links.Chat.Forum | Contact Me

" This is a collection of internet research done by myself and my family. I hope that I can help you by simply sharing this with you. I will continue to gather latest facts about NSCLC treatment, medications, and clinical trials. Let's share information for the benefit of lung cancer patients. "

N E W !!!
 
 

Frustrated by Ineffective Cancer Therapies ? Do you know any terminally ill cancer patient ?

Suffering from Chemotherapy side effects ? Do not lose Hope !

Safe Herbal Cancer Treatment is here. Treat Cancer, Naturally with CARCTOL - The Ray of Hope.

 

It all started around 1968, when a young man working with tribals of Assam(India) discovered astonishing properties of some herbs ,those when ingested, produced miraculous results in world healing. This young man, Dr. Nandlal Tiwari has been since then continuously experimenting this natural formulation among cancer patients.    

CARCTOL is a thoroughly researched herbal cancer therapy produced from Natural herbs made into a powerful herbal dietary supplement.    

Safe and harmless, CARCTOL treats all types of cancer which includes Cancer of the Esophagus, Ear, Nose Throat, Brain, Breast, Lymphoma, Lungs, Blood, Kidney, Cervix, Stomach, Colorectal, Pancreas and Hepatobilliary Cancer.  

 

Testimonial - " My mother Aged 60 now was suffering from Diabetes and Malignant Melanoma in ascending colone, in the year of 1996. Her platelet count was decreasing day by day. At All India Institute of Medical Sciences (New Delhi) she was advised to operate and with an external bag for faeces and life was counted for only 3 months. One of the doctor from AIIMS had suggested to see Dr. Tiwari. we met him and my mother was undergoing treatement with the carctol for about three years. Just after one year of administration of the CARCTOL under the medical supervision of Dr. Tiwari, my mother was again taken to AIIMS for checking. It was miracle that she didn't had any traces of cancer.As per the advice of Dr. Tiwari she took medicines for another two years. She is quite healthy now. My sincere Gratitude to Dr. Tiwari"

- Dr. S. Sen, New Delhi INDIA

 

Cancer Treatment using Carctol : How does Carctol Work?

What is CARCTOL ?

 

CARCTOL is a gift of timeless knowledge of Ayurveda. What started as a precious mix of herbs in powdered form, has been refined over the years as a Herbal Dietary Supplement (in capsules). 

 

Today CARCTOL is a herbal compound containing only rare, natural and indigenous Indian Herbs mixed together with proportional strength to treat and heal all types of Cancer.

 

This Herbal Cancer Treatment, CARCTOL is distinguished from other conventional anti-cancer drugs for the fact that it does not cause any side effects, has ZERO Toxicity and is backed by Pharmacological data. Besides healing Cancer, it also neutralises toxicity produced by chemotherapeutic agents.

 

CARCTOL Treats CA-Cervix, Ca Esophagus, Leukaemia Myoblastic and Lymphoblastic and other Cancers of Soft Tissues.

 

Composition of CARCTOL

 

Each CARCTOL capsule of 500 mg contains :

Hemidesmus Indicus - 20 mg

Tribulus Terrestris - 20 mg

Piper Cubeba Linn - 120 mg

Ammani Vesicatoria - 20 mg

Lepidium Sativum Linn - 20 mg

Blepharis Edulis - 200 mg

Smilax China Linn - 80 mg

Rheumemodi Wall - 20 mg

 

 

 

Advantages of CARCTOL

 

Oral Administration

Effective against multi-drug resistance

Well Tolerated

Cost Effective

Prevents Recurrences of Secondaries.

Relieves Despondency

Also effective for those patients who are troubled by the side-effects of chemo-therapy and radiotherapy

Dosage Instructions

  Adult (Stage 1 or 2) 1 capsule 4 times a day

Adult (Chronic/Terminal Cases) 2 Capsules 4 times a day

Child 1/2 * 4 times a day

Infant 1/4 * 4 times a day

 

* In cases of Children and Infants, capsule has to be opened, and the contents inside have to be divided as per dosage. For example in case of a child, 1/2 of the content of a capsule has to be given each time , 4 times in a day. The contents can ideally be fully dissolved in milk and then given.

 

In chronic cases, the dosage can be also be increased to 6 to 8 capsules a day, in proportion or as recommended by the physician.

 

Duration

 

An adult has to take one CARCTOL capsule normally four times a day i.e. at 8 AM - 12 Noon - 4 pm - 8 pm strictly after meals or light refreshments with milk or water. You can vary the above times giving a strict 4 hour gaps as per your meal schedule. For any clarifications, click here to write to us.

 

The dosage may be increased upto 6 to 8 capsules a day considering the advancement of malignancy in the patient. Since CARCTOL capsule contains herbs, it has a slow action. To be assured of its efficacy, one should continue it strictly as per dosage schedule for atleast 60 days (2 months) for the Initial Response and then to continue as per physician's advise. CARCTOL capsules are to be continued for six more months even after obtaining "No Evidence of Maligancy" report from a reputed diagnostic laboratory. It is important not to interrupt the daily dosage in any case. During the treatment, if any other ailment develops, required treatment can be taken by consulting your family physician. CARCTOL does not interfere or cross-react with any medicine.

 

Precautions

 

Anything that tastes sour must be avoided. Read our FAQ here for more details.

Sufficient quantity of "Boiled and then cooled" water should be taken during the administration of CARCTOL.

It is also advised that consumption of liquor, tobacco in any form and non-vegetarian food should be avoided.

© IvyComm Systems

1405, Sector 14, Faridabad HR 121007, India.

Tel : 00 91 9818181405

Fax : 00 91 129 5003781

 

Dr. Nandlal Tiwari  

Internationally acclaimed ayurvedic specialist Dr. Nandlal Tiwari has been treating terminally cancer patients with his special herbal cancer therapy for the past 20 years with a fair measure of success. 

 

He invented CARCTOL from experiments done on valuable information he gathered from the tribals in ASSAM forests in India during his research on herbs there. He claims that his findings proved effective in almost all types of cancer.

 

Dr. Tiwari, is from Jaipur, Rajasthan, India treats only terminally ill patients and claims to have success rate of between 30 to 40 percent. 

 

Dr. Tiwari feels that modern medical practitioners should take up research projects to understand how CARCTOL, the alternative cancer treatment works on the body. 

 

Dr. Tiwari has been receiving recognition from all over the world and Central governments of various countries have been asked to test and work on this formulation to refine it even further. 

 

He has travelled and treated patients worldwide, including Germany, Australia, Sweden, Britain and Kenya. CARCTOL, his invention is a blend comprising eight herbal ingredients, which he said he came up with after much rigorous trial and experiment. 

 

"Ayurvedic treatment works because of the correct mixture of the herbs. It is different from the medicines prescribed by general practitioners because of their chemical ingredients." 

 

Dr. Tiwari who has appeared on BBC television in a documentary and several other documentaries in India to report on his herbal cancer treatment said, he provided, "A Ray of Hope" for patients, who sought him as a last resort.  

 

Q : What is Carctol?

 A : Carctol is a herbal remedy made from pure Indian Herbs for treating all types of Cancer. You can find all information about it by clicking here. Browse through this FAQ for more common questions. If you still have some query unanswered, write to us.   

 

 

 

 

 

Q : Who all can take CARCTOL? Does it benefit only people with Cancer?

A : CARCTOL is a herbal remedy for cancer as well as a powerful general tonic. Though it is generally taken by people with cancer or tumors, it is very safe and harmless that even non-cancer patients can also take it. So much so EVEN if a person having no disease whatsoever may safely take it for 6 months with no harm done.

 

Those patients who have been taking Tobacco or having whooping cough or difficulty in swallowing food may take CARCTOL. In such cases, carctol treats these problems with positive results. Even women who are victims of semenal passing, monthly gynaecological disorders, falling appetite, liver damage due to access of alcohol OR any type of vaginal disorders may also take CARCTOL with good results. 

 

Q : What are the dosage instructions of taking CARCTOL?

A : Detailed dosage Instructions can be read here. If you still have any queries, do write to us.

In brief, Adult 1 capsule 4 times a day

Child 1/2 * 4 times a day

Infant 1/4 * 4 times a day

* In cases of Children and Infants, capsule has to be opened, and the contents inside have to be divided as per dosage. For example in case of a child, 1/2 of the content of a capsule has to be given each time , 4 times in a day. The contents can ideally be fully dissolved in milk and then given. 

 

Q : Can we take CARCTOL in the morning or with an empty stomach?

A : CARCTOL should not be taken in the morning with an empty stomach. CARCTOL capsule should generally be taken 4 times a day with a little water. It is advisable to take a cup of milk immediately after each dose however not necessary. If there be any difficulty in swallowing the capsule, the contents of the capsule may be mixed in milk and then taken. The number of doses may be increased from 4 times a day to 6 times a day or even 8 times a day depending upon the chronicity and malignancy of patient's cancer.

 

Q : How long does CARCTOL take to act or show its effects?

A : CARCTOL generally takes around 60 days or approximately 2 months for an INITIAL RESPONSE. As CARCTOL is a sum-total or a combination of only pure herbs, its effect will be slow and steady. Hence it should be taken regularly for two months. If the medicine proves to be effective within two months, continue the medicine. If there is no sign of improvement within two months, the medicine may be discontinued.

 

Note : In any case if the patient thinks of discontinuing the medicine in less than two months, he/she might as well not take it at all.

 

Q : How will the patient know whether CARCTOL is working or not? How can we be sure that the cancer is healing due to its action?

A : Sometimes the patient would like to know the efficacy of the medicine. Many people think as to how will they be able to know whether CARCTOL is working or not. Dr. Tiwari believes that if the medicine is working, then patient will feel the improvement within. This can be ascertained and observed within two months by the general feeling of the patient. Only when the patient feels satisfied of the improvement, should the medicine be continued beyond two months or else it must be stopped henceforth.

Q : While taking CARCTOL, if there is some other disease, what should be done? Can I take other medicines along with CARCTOL without adverse effects?

A : While undergoing the "CARCTOL" treatment, if the patient is struck by any other disease or physical difficulty apart from cancer, he /she may be taken to the concerned doctor for consultation. Any medicines prescribed by Doctor may be taken without discontinuing the "CARCTOL" capsules provided that a gap of half an hour is given between these two medicines. It means that CARCTOL never reacts with any of the other medicines being taken by the patient.   T

 

Q : Is CARCTOL harmful? Does it cause any side effects ?

A : CARCTOL is absoloutely safe and harmless. Whether "CARCTOL" cures your cancer or not, one must remember that IT WILL NOT do any harm to the patient. Obtained and made from completely natural resources, it can never cause any harm or side effects. So much so EVEN if a person having no disease whatsoever may safely take it for 6 months with no harm done. 

 

Q : Is CARCTOL toxic? Has it been tested for toxicity?

A : CARCTOL is made from pure herbs. It has already been tested at All India Institute of Medical Sciences Laboratory New Delhi and has been cleared of causing any side effects on human body. Carctol was also tested at Lyne, Martin and Radford Laboratory at London. These Certificate of Analysis and other relevant test reports are available upon request.

 

CARCTOL is a product prepared on the guidelines laid down by the Drugs Act in India. CARCTOL has no metal, remains of any burnt objects/herbs , intoxicating elements, poison, juices of chemicals of any kind that may injur or impair human life. It is an absoloutely SAFE medication and can be taken as a WHOLE HERBAL FOOD OR DIETARY SUPPLEMENT. 

 

 

Q : What are the DOs and DONTs while taking CARCTOL? Are there any dietary restrictions while taking it?

A : "Pre-boiled and then cooled" water should be given to the patient. As far as it is practical, the patient should avoid plain water. The patient must be given as much as possible in order to create more urine. This process is beneficial in curing the patient.

 

The patient should avoid ALL SOUR things during the treatment. However, in case of sickness, if the Doctor prescribes a medicine which is sour or Vitamin "C", there is no bar to that. But in no case, sour things are not to be taken by the patient. There are certain things which are sour in the beginning or in course of eating towards the end. For example - Mango. Mango is sour when raw but sweet when ripe. Another example is CURD. In the beginning it is sweet but after a few hours it becomes sour. So things or foods like these should not be taken. Sour things contain acids which are already present in the body. Taking sour things unnecessarily adds more acids to the body which are not needed and will only hamper the progress made by CARCTOL. However, fruits like bananas, papaya and vegetables like carrot or its juice, coconut juice can be taken. Any food which cannot be digested easily by the patient should not be given. Milk should only be taken depending upon the patient's digestion capacity and power.

 

Patients should be able to digest all food intake well. If their digestion is not upto the mark as is the case with 70% of the people in this world, they should consult their physician and take some appropriate medicine for improving digestion. CARCTOL works better when the digestion capacity of the patient is good. 

 

Q : Why should not I take Sour things(food that is sour in nature or have sour properties) while taking CARCTOL?

A : According to Dr. Tiwari, "Foods taste Sour till the time they are tasted by your tongue. Once they are digested and assimilated, you cannot tell whether it is sour or sweet.". As to why foods having SOUR properties should not be taken is because All things sour in taste or nature are acidic. They release acids when taken and these unnecessary acids get accumulated into the body. Many of these acids are already present in the body and your body does not need any additional acids. These acids affect the efficacy and action of CARCTOL and are not good for healing tumors and cancers. Hence, we strictly advise not to take foods with Sour properties.

 

Examples of SOUR food are : Tomato, tangerine, plum, lemon, grape, haw, cherry apple, pomegranate, vinegar, curd, Mango. Some doctors may advise any of these foods, but please bear in mind that these sour foods may hamper the action and effect of CARCTOL.

 

Q : Can I take non-vegetarian food while taking carctol? Is it mandatory to take vegetarian food?

A : It is advised that a patient should maintain a vegetarian diet. However, if you are taking any non-vegetarian food, please make sure that it is easily digested and that it is not sour in any form.  

 

Q : What are the other benefits of CARCTOL besides healing Cancer?

A : CARCTOL is a general healer of all kinds of tumors. It also treats and removes all the symptoms and side effects caused by Chemotherapy and RadioTherapy. Those patients who have been taking Tobacco or having whooping cough or difficulty in swallowing food may take CARCTOL. In such cases, carctol treats these problems with positive results. Even women who are victims of semenal passing, monthly gynaecological disorders, falling appetite, liver damage due to access of alcohol OR any type of vaginal disorders may also take CARCTOL with good results.

 

Q : Will everyone be fully cured off Cancer by using CARCTOL? Do you make any claims or guarantees for Cure with CARCTOL?

A : One should not be under any misconception that 100% patients would be fully cured by CARCTOL. We have clearly mentioned that we have seen a 30% to 40% success rate with CARCTOL in cancer patients. This success rate is considered to be very high particularly when the disease we deal with is CANCER (even malign CANCER). Hence only 30% to 40% patients who come under CARCTOL's control are generally cured and the rest do not. In other cases, where there might not be a complete healing of cancer, there are strong chances of a significant improvement. Hence, please do not associate words like "Assurance", "Guarantee" , "Surety" , "Claim" with this medicine. We believe that even if 30 out of 100 patients are benefitted, CARCTOL has played its part well in healing the world. Patients who feel despondent, frustrated, give up hopes of their lives, or to whom doctors have refused for any further treatment are advised to try CARCTOL for 2 months.

 

 

 

Q : Will CARCTOL help me if I have Ascites i.e. accumulation of fluid in abdominal cavity?

A : It is seen that CARCTOL is not very effective in those patients who have ASCITES. But it is observed that it still works in 5% of cases which have ASCITIS involved. Read below for definition of ASCITES.

 

Q : What is Ascites?

A : Inside the abdomen there is a membrane called the peritoneum which has two layers. One layer lines the abdominal wall and the other layer covers the organs inside the abdominal cavity. The peritoneum produces a fluid that acts a lubricant and allows the abdominal organs to glide smoothly over one another. Sometimes an excess of this fluid can build up between the two layers and this is called ascites. Ascites can be a symptom of many types of cancer. The types of cancer that are more likely to cause ascites are: cancer of the ovary, lining of the womb (endometrium), breast, bronchus (main airway), large bowel (colon), stomach and pancreas. 

 

Q : Why do you advise buying a 2 month supply for newer patients. Why should not I try for only 1 month?

A : CARCTOL is a sum-total or a combination of only pure herbs, its effect will be slow and steady. Hence it should be taken regularly for two months. If the medicine proves to be effective within two months, continue the medicine. If there is no sign of improvement within two months, the medicine may be discontinued. In any case if the patient thinks of discontinuing the medicine in less than two months, he/she might as well not take it at all.

 

Please Note : CARCTOL has been economically priced to help cancer patients. It is way below the costs that an average cancer patient incurs on chemotherapy, and other conventional methods of treatment and paying for their medical bills.

 

Between 1985 to 1989, 1900 patients with terminal stage were treated.

The success of this trial is depicted below :

 

 Grade A = 80-100% symptome free upto 2yrs then left the follow up

 Grade B = 50-80% symptomatic improvement, then left the follow up

 Grade C = 5-50% improvement, then left the follow up

 Grade D = Those who took it for two months only

 

Zero Toxicity Report

CARCTOL has been tested for Zero Toxicity at All India Institute of Medical Sciences and also at -

Lyne, Martin & Radford, UK. Both these toxicity test reports are available upon request to patients and researchers.

Severn Trent Laboratories in Coventry, UK has also issued a Lab Test Report after doing a thorough Compound and Multiresidue Analysis. All these reports are also available upon request.

 

PREVENTION IS BETTER THAN CURE

 

For individuals with potential hazard of cancer like smokers, tobacco addicts, drug addicts, alcoholics, residents of highly polluted areas, patients of chronic coughs, ulcers, women with consistent leucorrhoea problems and such other health hazards are strongly recomended to take CARCTOL regularly.

 

In addition families with history of cancer patients are also advised to use CARCTOL as a preventive meassure.

 

Over the years, during Dr. Tiwari's research, he has received many worthy mentions in various newspapers, magazines and health publications. 

We attempt to launch CARCTOL publicly through this website and we would be updating this section as and when there are more press releases outside India.  

 

Outside India 

 

Dr. Tiwari has appeared in numerous interviews in United Kingdom in both print and television including a BBC Documentary. 

 

In print, here is a writeup published in The Sunday Tribune in South Africa.  

Download as Text | Download as Scanned Image(Jpeg) 

 

Till now, CARCTOL has received mentions in numerous publications (most of them which are Indian). Listed below are few of these. We will be updating this section with English versions of these writeups very soon. 

 

The Assam Tribune - Feb 27, 1990

The Hitavada - November 10, 1984

United News of India - March 12, 1994

Indian Express - Feb 27, 1990

Hindustan Times - Feb 26, 1990

Dainik NavJyoti - 17 April 2001

Patheya Kan - November 1998

Kadambari - January 1994

Vishwa Rakshak - 5th April 2001

Ranchi Express - 1 June 2001

Sanmarg - 14 June 1999

 

CARCTOL is now available for ordering and can be shipped to all parts of the world. We have designed ergonomical packs for all the patients for ease of use.   

*Note* : For initial trial purposes, we strongly advise that CARCTOL must be taken for atleast 60 days or 2 months for it to show effects. CARCTOL, made from pure natural herbs takes atleast 60 days for the INITIAL RESPONSE.   

 

Dosage Instructions  

    Adult (Early Stage :I,II) 1 capsule 4 times a day

Adult (Chronic/Terminal Cases) 2 Capsules 4 times a day

Child 1/2 * 4 times a day

Infant 1/4 * 4 times a day

* In cases of Children and Infants, capsule has to be opened, and the contents inside have to be divided as per dosage. For example in case of a child, 1/2 of the content of a capsule has to be given each time , 4 times in a day. The contents can ideally be fully dissolved in milk and then given.  

 

Each Box of CARCTOL contains 120 capsules. Each box is priced uniformly throughout the world for USD 69.95. We accept all major credit cards and we use 2Checkout.com Payment Gateway for Secure 128 bit encrypted transactions)   

  

Following packs are available :   

 

>> 2 boxes of 120 capsules = 240 Capsules : US$ 124.95   

Click here to buy  (You save $15 here)   

 

>> 4 boxes of 120 capsules = 480 capsules : US$ 209.95   

Click here to buy  (You save $70 here)   

 

>> 6 boxes of 120 capsules = 720 capsules : US$ 299.95   

Click here to buy  (Super Saver Pack. It saves you $120)   

 

>> 1 box of 120 Capsules (Not Recommended for new patients)   

US$ 69.95 each. Click here to buy.   

 

Shipping Information   

 

All orders are shipped within 72 hours by EMS or Airborne Express. Expected time of Delivery is within 8 days of ordering.   

 

Refund Policy   

 

- In case the customer is dissatisfied with the product, we will accept the product back within 30 days of ordering and refund the amount back to your credit card. However, shipping charges are not refundable and a fixed $15 charge as shipping will be deducted from the refund amount.   

- In case the product ordered by you is never received, please write to us. We will let you know the status within 48 hours. In case we are not able to produce the proof of delivery, we will be happy to refund the full amount.   

- We resolve all refund inquiries within 72 hours and maintain a shopper-friendly refund policy.

 Go to >>   

>> Read about Dr. Nandlal Tiwari   

>> Frequently Asked Questions   

>> About the Medicine   

>> Clinical Trials of CARCTOL    

>> Press Releases   

>> Questions? Give us your feedback   

>> Sign up for our Newsletter   

 

"God has not given us any disease for which he has not provided a remedy." - Paracelsus   

 

Call us at : (+91) 981 8181405  

Fax : +91 129 5003781 (India)   

 

Secure Online shopping with CCAvenue.com

CCAvenues.com is our online retailer. Our shopping-cart software runs in Secure Mode on the Online Shopper's browser, using SSL (Secure Sockets Layer) to encrypt sensitive data such as credit card numbers. All charges will be billed and appear as "CCAvenues.com" on your credit card statement.

 

While selecting products and adding them to the Shopping Cart, the Online Shopper is in Non-Secure Mode. After he/she presses the Checkout button, we switch to Secure Mode in order to collect the billing and shipping information.  All modern Web browsers support the SSL standard, but the Online Shopper can choose to checkout using Non-Secure Mode if necessary.

 
 

Waging War On Lung Cancer

 

Five years ago, when Ken Giddes was vacationing with his wife in Vancouver, British Columbia, the 61-year-old resident of Atlanta began feeling short of breath. But since he was "running around quite a bit," Giddes chalked up his problem to being an overachieving tourist. When he returned home, though, his shortness of breath persisted. The cause--uncovered by an x-ray--was a collapsed lung.

 

But it wasn't until he underwent surgery to repair his lung, that the cause of the collapse was clear: lung cancer had eaten a hole in the air sack of his lung. After surgeons removed his lung in an effort to contain the cancer, they checked Giddes for any traces of cancer every three months. Within a year there was more bad news: a CT scan revealed 13 spots on his remaining lung.

 

Surgery revealed the cancer had spread throughout his remaining lung. Giddes recalled that he was given less than a 30 percent chance of living another two years. But he decided to battle the cancer "with all the energy, hope and positive attitude I could muster." After 30 weeks of chemotherapy, he was told his cancer was in remission.

 

Today, he's glad he didn't give up because he's beaten the odds, surviving five years since his cancer was diagnosed. And as the head of the Caring Ambassador Program, sponsored by Republic Financial Corporation, he's helping other cancer survivors wage war on lung cancer, too.

 

Survival and Detection

 

Lung cancer is the leading cause of cancer deaths among both men and women, according to the American Cancer Society. Since 1987, more women have died each year of lung cancer than of breast cancer.

 

Detecting lung cancer in its early stages is difficult in some cases because the disease spreads very quickly and symptoms often don't appear until the disease is advanced. Only about 15 percent of lung cancers are found before the cells have spread to lymph nodes or distant organs.

 

Still, the survival rate for the disease has improved over the years. The one-year survival rate for patients is about 40 percent today compared with 32 percent in 1973. And five-year survival is up from 8 percent in the 1960s to 14 percent today. Improvement in survival rates can be attributed, at least partially, to diagnostics and new drugs that the Food and Drug Administration has approved.

 

Lung cancer can be diagnosed by:

a chest x-ray or CT scan to check for spots on the lungs

a microscopic analysis of phlegm cells

a bronchoscopy, which involves passing a lighted tube through the tubes that carry air to the lungs to see if tumors or blockages exist.

If suspicious tissue or spots are detected, a needle biopsy is typically performed, so that a sample of the tumor can be obtained to confirm the diagnosis of lung cancer.

 

There also are two other diagnostic tools that may be used in place of a biopsy.

 

The Xillix LIFE-Lung Fluorescence Endoscopy System is a medical device FDA approved in 1996 for detecting bronchial tissue abnormalities in patients with previous, current or suspected lung cancer. A tube inserted through a patient's mouth into the bronchi (tubes leading from the trachea to the lungs) delivers a blue laser light to the bronchial tissue. The image the laser reveals is projected onto a video monitor. While normal tissue appears green, abnormal tissue will appear reddish brown. Suspicious areas can then be biopsied. The system was approved for use in conjunction with conventional white light bronchoscopy. While the illumination provided by the white light helps doctors identify tissue that looks abnormal, the new blue laser system detects more tissue changes than can be seen with the white light alone.

 

The approval of this device is significant, says Harry Sauberman, chief of the ear, nose and throat devices branch in FDA's Center for Devices and Radiological Health. It can spot moderate to severe dysplasia (irregular tissue), "some of which may turn out to be malignant and you'll have a case of lung cancer," he explains. Patients with dysplasia can then be closely monitored, and if cancer appears, it can be treated in its earliest stages.

 

The second diagnostic tool is an imaging agent called Nofetumomab (verluma). Approved by FDA in 1996, it can determine the extent of disease in patients already diagnosed with small cell lung cancer through a biopsy but who have not yet been treated. Nofetumomab is a fragment of a monoclonal (synthetic) antibody that, when tagged with a radioisotope, can detect a protein found on the surface of most small cell lung cancers. The antibody collects in tumor sites and other areas of the body where protein is detected and, using special cameras, doctors can see the areas as "hotspots." This information helps physicians see how far the cancer has spread without exploratory surgery or other diagnostic tests and allows them to develop a more effective treatment plan.

 

According to Patricia Keegan, M.D., deputy director for the division of clinical trials design and analysis in FDA's Center for Biologics Evaluation and Research, the major advantage of using the imaging agent is that it allows doctors to do a full body scan of a patient. "The disadvantage is that it isn't as sensitive in any one area as other scans," she says. "It's not as good as a CT scan for picking up every liver metastasis. And it isn't as good as an MRI or CT scan of the head to pick up brain metastasis. But if all you want is a quick and dirty answer about whether the cancer is widely disseminated or not, it's a relatively simple test to do."

 

Treatment

 

About 75 percent of lung cancer cases are categorized as non-small cell lung cancer, and the other 25 percent are small cell lung cancer. Lung cancer can multiply quickly and form large tumors, which sometimes spread to lymph nodes and other organs.

 

Once lung cancer is detected, a treatment plan is developed based on the patient's physical health, whether the lung cancer is small cell or non-small cell and how extensively the cancer has spread. (See "Stages of Lung Cancer.") Treatment may include surgery, chemotherapy, radiation, or a combination of two or more of these therapies.

 

FDA recently approved three therapies to treat non-small cell lung cancer: Photofrin (porfimer sodium), Taxol (paclitaxel) in combination with the commonly used cancer drug cisplatin, and Gemzar (gemcitabine hydrochloride) in combination with cisplatin.

 

Photofrin, a light-activated drug, was approved in January 1998 for patients with early stage, non-small cell lung cancer who cannot undergo surgery or radiotherapy due to other medical conditions. Administered intravenously, Photofrin accumulates in the tumor cells. A laser, directed toward the cancerous tissue, then activates the drug. A significant side effect is extreme photosensitivity, making it necessary for patients to stay out of the sun "almost completely for about a month," says Grant Williams, M.D., a medical team leader in the division of oncology drug products in FDA's Center for Drug Evaluation and Research.

 

Williams admits that the number of patients with early stage lung cancer who will be helped by Photofrin will be quite limited. "We're talking about a very small number of patients compared to the number of lung cancer patients who have extensive cancers that can't be operated on," he says.

 

Williams notes, however, that Photofrin may also be able to relieve symptoms in some patients with advanced non-small cell lung cancer. He explains that Photofrin has been demonstrated to be helpful in relieving breathing difficulties caused by tumors that are obstructing the flow of air through patients' bronchial tubes. Approval for this use was recommended by an FDA advisory committee in September 1998. Final FDA action is pending.

 

Taxol (paclitaxel), already approved to treat other cancers, was approved last year for use in combination with cisplatin for the first-line treatment of non-small cell lung cancer in patients who are not candidates for surgery or radiation therapy.

 

Gemzar (gemcitabine hydrochloride), another already approved cancer drug, received an additional approval in August for use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced or metastatic non-small cell lung cancer.

 

Although results of some studies have shown that new treatments may only give patients an additional month or two to live, "there are not a lot of effective treatments for advanced stage non-small cell lung cancer," says Isagani Chico, M.D., a medical officer in FDA's division of oncology drug products.

 

Because small cell lung cancer has typically spread by the time it's detected, it generally cannot be cured by surgery. Treatment usually begins with a combination of two or more drugs to kill cancer cells throughout the body. Later, treatment with more drugs combined with radiation therapy or radiation alone, is often prescribed. Chemotherapy (drugs) and radiation therapy shrink tumors in most patients, and sometimes the disease goes into remission. But in many cases the cancer begins to grow again when it becomes resistant to treatment.

 

The Road Ahead

 

The future and course of lung cancer research seems to vary tremendously depending on who you talk to. Some experts believe prevention and early detection are the best bet. Others insist that improved treatments and gene therapy will be the answer. Paul Bunn Jr., M.D., believes that more research needs to be conducted to see if it's feasible to use x-rays to screen cigarette smokers and people exposed to asbestos, who are at highest risk of developing the disease. Bunn, the director of the University of Colorado Cancer Center and past chairman of FDA's Oncologic Drugs Advisory Committee, believes that the increased use of tobacco among teenagers and adults must be curtailed and that one of the best weapons against lung cancer is prevention.

 

As for lung cancer patient Ron Norgord, he's banking on a drug that's intended to cut off the blood supply to tumors using molecular technology. The 63-year-old resident of Pasadena, Calif., who has been on a variety of chemotherapy and radiotherapy treatments since he was diagnosed about a year and a half ago, was accepted in September into a clinical trial of a drug that inhibits the growth of tumor blood vessels at UCLA's Cancer Center. "I'm quite encouraged by the results so far," Norgord says. "It's too early to see yet, but I see some positive things coming out of the treatment." One positive sign came after his first treatment, when his chances for fighting infections improved because his white blood cell count finally came up into the normal range.

 

Researchers are currently studying a variety of drugs and drug combinations designed to extend patients' lives and improve their quality of life. They are also studying various aspects of the disease in the hope of someday developing more effective treatments. Here are just a few of the recent findings, studies and developments related to lung cancer:

 

Researchers at the Dana-Farber Cancer Institute and the Brigham and Women's Hospital in Boston have identified six factors that place patients with early-stage lung cancer at risk for recurrence. These factors include: large tumor size, a specific tumor subtype of adenocarcinoma (a type of lung cancer), evidence that the cancer has entered the channels of the lymph system, and the presence of certain proteins commonly associated with cancers. Patients with two or more of these risk factors have an increased chance of their cancers recurring. This knowledge may help doctors decide which patients would benefit most from chemotherapy after surgery.

The Radiation Therapy Oncology Group, a federally funded cancer clinical trials cooperative group, which carries out multi-disciplinary research nationwide, recently began a randomized clinical trial that will evaluate whether amifostine, a radio-protective agent, can effectively reduce some side effects in certain lung cancer patients treated with combined radiation therapy and chemotherapy. The trial, which will study patients with inoperable non-small cell lung cancer, is important because lung cancer patients who are treated with radiation and chemotherapy sometimes develop inflammation of the esophagus, making it difficult for them to swallow.

At an American Association for Cancer research meeting in March, E. Premkumar Reddy, Ph.D., director of the Fels Institute for Cancer Research at Temple University School of Medicine in Philadelphia, reported that discovery of a new pathway for tumor growth may help researchers develop new types of diagnostic tests and anti-cancer agents. The new pathway, Src-Stat-3, is believed to play a critical role in the proliferation of cancer cells in the lung, breast, prostate, and ovary.

 

Meanwhile, lung cancer survivor Ken Giddes, who is also a voting patient representative on FDA's Oncology Drug Advisory Committee, continues to spread a message of hope to people throughout the country. "I want people to know that the diagnosis of cancer is not an automatic death sentence and to inform people of the many options available to them," he says. "I also want people to know that just because they have lung cancer they shouldn't be written off or forgotten. People try to make you feel bad, especially if you smoked, like it's your own fault. But I see plenty of people who have lung cancer and haven't smoked. And even if they did smoke, they didn't plan to get lung cancer."

 

Ellen Brown is a writer in Lakewood, Ohio.

 

 

 

The Risks of Smoking

 

You have undoubtedly heard the warnings: if you smoke cigarettes, stop now, and if you don't smoke, don't start. Why? Because cigarette smoke is made up of over 4,000 chemicals, including 43 known to cause cancer. According to the American Cancer Society, tobacco use accounts for 30 percent of all cancer deaths in the United States, and smoking is responsible for 90 percent of lung cancers in men and more then 70 percent in women. The ACS estimates that 28 percent of men, 23 percent of women, and about 30 percent of adolescents smoke.

 

According to the American Lung Association, the more you smoke and the longer you smoke, the more likely you are to develop lung cancer. But the ACS contends that if you quit smoking when precancerous signs are found, the damaged lung tissue often may return to normal, oftentimes within five years.

 

There has been some debate, however, on this subject. In 1997, researchers at the University of Pittsburgh Cancer Institute concluded after a preliminary study, that just because people quit smoking doesn't mean they won't develop lung cancer at some point in their lives. The study, which was published in the American Journal of Respiratory and Critical Care Medicine, determined that 77 percent of the people who smoked at least a pack of cigarettes a day for 25 years had irregularities in their lung cells even if they weren't smoking at the time the lung tissue was examined. While those who smoked fewer cigarettes weren't home free, they were less likely to develop abnormal lung cells. Only about 15 percent of the people who smoked for less than 25 years showed similar cellular changes.

 

More research still needs to be conducted on this topic, and most doctors still recommend that people stop smoking, no matter how long they've been keeping up the habit. This is especially true for people who have been diagnosed with lung cancer. "People with lung cancer who stop smoking live longer and have higher cure rates and lower rates of second cancers, which is a major problem for these patients," says Paul Bunn Jr., M.D., director of the University of Colorado Cancer Center and past president of the International Association for the Study of Lung Cancer. "They also have lowered risk of death from other problems such as heart disease." Bunn says it's a myth that most lung cancer patients don't quit smoking; in fact, they have a much higher quit rate, he says.

 

For more information on how to quit smoking, see "It's Quittin' Time" in the November-December 1997 FDA Consumer.

 

Lung Cancer Warning Signs

 

Detecting lung cancer in its early stages can lead to a cure for some people and extend the life of others, according to the American Cancer Society. So, if you are experiencing any of the following problems or symptoms, seek medical attention at once:

 

a persistent cough

chest pain

weight loss and/or decreased appetite

bloody phlegm

shortness of breath

hoarseness

a fever for an unknown reason

recurring infections, such as bronchitis and pneumonia.

Some of these symptoms may be related to another disease or condition. The only way to know if you have lung cancer is for a doctor to perform the necessary tests.

 

Stages of Lung Cancer

Lung cancer treatment depends on tumor size and on how far the cancer has spread. To help doctors decide on the best treatment plan for their patients, a system of stages that describes the growth and spread of the cancer has been developed.

 

There are two stages for small cell lung cancer. In the limited stage, the tumor is usually confined to one lung and lymph nodes on the same side of the chest. In the extensive stage, the cancer has spread to the other lung and to lymph nodes on the other side of the chest, or to distant organs.

 

The stages of non-small cell lung cancer are:

 

Occult Stage:

Cancer can be detected in patient's saliva, but tumors cannot be found in the lungs.

Stage 0:

Cancer is localized in a few layers of cells and has not grown through the lung's top lining.

Stage I:

The tumor is only in the lung and surrounded by normal tissue.

Stage II:

Cancer has spread to nearby lymph nodes.

Stage III:

Cancer has spread to the chest wall or diaphragm near the lung, or to the lymph nodes in the mediastinum (the area that separates the two lungs), or to the lymph nodes on the other side of the chest or in the neck. This stage is divided into IIIA, which can usually be operated on, and stage IIIB, which usually cannot withstand surgery.

Stage IV:

The cancer has spread to other parts of the body.

Recurrent:

Cancer has returned after treatment.

 

by Ellen Brown

 

The Cancer Network ( Green tea)

 

Green tea is widely consumed in Asian countries, especially China and Japan. It has been suggested that green tea has a protective effect against the development of stomach adenocarcinoma, the second leading cause of cancer death throughout the world. Although laboratory experiments and some case-control studies have shown that some chemicals extracted from green tea may inhibit development of several types of cancer, a recent study published in the New England Journal of Medicine did not confirm such preventive effects.

Dr. Yoshitaka Tsubono and colleagues from the Department of Public Health and Forensic Medicine at Tohoku University Graduate School of Medicine conducted a large population-based, prospective cohort study in three municipalities in northern Japan. A total of 26,611 individuals were studied between January 1988 and December 1992. The majority of the studied subjects were 40 years of age or older. All patients were required to complete a self- administered questionnaire that included questions about the frequency and amount of green tea consumed, and were followed up with screening examinations for adenocarcinoma of the stomach for at least 8 years.

 

During the 8-year follow-up, approximately 420 patients were diagnosed with stomach cancer. Of these patients, 296 were men and 123 were women. The incidence of stomach cancer among all the studied subjects was analyzed by utilizing several sophisticated statistics models, and the relative risk of gastric cancer according to the consumption of green tea was estimated. The researchers found that green tea consumption does not decrease the risk of gastric cancer. Individuals who drink one or two, three or four, and five or more cups of green tea daily have a similar risk of developing stomach carcinoma as people who drink less than one cup per day.

 

"In conclusion, in a prospective cohort study, we found no association -- inverse or otherwise -- between the consumption of green tea and the risk of gastric cancer in Japan," said Dr. Tsubono.

 

Reference: Green tea and the risk of gastric cancer in Japan. New England Journal of Medicine 2001 Mar 1; 344 (9):632-6

 

This article is copyrighted by The Cancer Information NetworkTM -- a leading national organization dedicated to cancer patients and their caregivers. This article may be transmitted freely with this contact and attribution information. For more information on cancer, cancer diagnosis and treatment, visit http://www.thecancer.info.

 

Deborah Shaffer had metastatic Lung Cancer, but her tumors are shrinking  

Alimta: An Emerging Treatment Option for Relapsed Lung Cancer

Iressa

Approval of

First Targeted Drug for Lung Cancer

Lung Cancer Treatments

  

New Lung Cancer Therapies

by Cathy Dunn & Amy DOrazio, PhD

 

Deborah Shaffer is playing a lot these days, enjoying her family, and riding horses on her farm in Cleveland, Texas, outside Houston. Shes just following doctors orders, she says. The doctor told me in January to go home and play, says Shaffer, who is 52.

 

For Shaffer it was good news. A smoker for 30 years, Shaffer was diagnosed with stage IV (metastatic) lung cancer in April 2002. She had brain surgery to remove a metastatic tumor, and in January 2003 tests showed that the tumors in her lungs were continuing to shrink after her six-month chemotherapy regimen of Paraplatin® (carboplatin) and Taxotere® (docetaxel) that ended in October 2002. Physicians would like to see success stories like Shaffer more often. Lung cancer is one of the most common cancers in the United Statesand, by far, the most deadly. In fact, more people die from lung cancer than from colon, prostate, and breast cancer combined.

 

A Difficult Cancer

 

Nobody knows for sure why lung cancer is so difficult to treat effectively. But the answer may be inherent in the structure of lung cells, says Alex Adjei, MD, faculty member at the Mayo Clinic, Rochester, Minnesota.

Because the lungs are important for breathing and are frequently exposed to unhealthy environmental elements, nature has made the cells lining the lungs extremely resistant to damage and death, Dr. Adjei says. When these cells become cancerous, their survival properties are magnified, making them very difficult to kill with chemotherapy.

 

Complicating matters is the fact that the disease is often difficult to diagnose in its early stages. Although many people undergo high-resolution spiral CT to screen for lung cancer, so far, the U.S. Food and Drug Administration (FDA) has not approved a screening method for lung cancer.

 

Adding to the complexity are the numerous types of the disease. Even the most common type, nonsmall-cell lung cancer (NSCLC), is further divided into three categories: 1) squamous cell (similar to cells of the skin); 2) adenocarcinoma (a cancer of the mucous glands); and 3) large cell. A less common subtype of adenocarcinoma, called bronchoalveolar carcinoma, is seen more commonly in women and people who have never smoked. If that isnt confusing enough, NSCLC is defined by stages using the International Staging System for Lung Cancer. The system classifies a tumor according to size (T), involvement of lymph nodes (N), and amount and location of cancer spread (metastasis) to other parts of the body (M). Different treatment options are prescribed for each stage.

 

Many people who have undiagnosed lung cancer dont know anything is wrong; others experience symptomssuch as a nagging cough or hoarsenessthat may be explained by other causes such as upper respiratory problems. By the time a diagnosis is made, the disease may have spread to other organs. In fact, about 85% of lung cancer cases are not identified until the later stages.

 

Finding the Good News

 

Thats the bad news. The good news is that lung cancer patients are beating the odds by working closely with their doctors, educating themselves about innovative treatments, and acting quickly to combat the disease. In some cases, that means undergoing traditional treatment such as surgery, radiation, or chemotherapy. In other cases, participation in a clinical trial testing a new medication may be a patients best chance for survival.

 

Doctors have an arsenal of chemotherapy drugs to treat lung cancer, with each stage and type responding differently to various drugs. For Shaffer the carboplatin/Taxotere combination worked.

Even as recently as the 1980s, doctors were unsure whether it was worthwhile to treat patients with advanced lung cancer with chemotherapy. However, after a series of clinical trials showed that chemotherapy with Platinol® (cisplatin) could prolong life and relieve symptoms, chemotherapy became more widely accepted.

 

Since that time several new agents have been developed (see sidebar, page 23). These include Taxol® (paclitaxel), Taxotere, Navelbine® (vinorelbine), Gemzar® (gemcitabine), and Camptosar® (irinotecan). With the exception of Camptosar, each has FDA approval for use in lung cancer patients. It has been found that these agents are most effective when combined as a doublet with cisplatin or carboplatin, a modified form of cisplatin that is better tolerated by most patients.

 

 

Shaffer found her treatment with carboplatin/Taxotere tolerable. The first treatment I didnt have any side effects, but the second one I was nauseated and had diarrhea, she explains. But it was manageable. I knew when I was being treated and planned for it.

 

Analysis of numerous trials involving thousands of patients has shown that each of these agents alone leads to tumor shrinkage in about 20-25% of patients. When combined as a doublet with cisplatin or carboplatin, that figure increases to around 30%. The most well-known trial comparing these regimens was conducted by Eastern Cooperative Oncology Group (ECOG), which compared Gemzar/cisplatin, Taxol/carboplatin, and Taxotere/cisplatin to Taxol/cisplatin. The study found that each regimen was approximately equal in its ability to shrink the tumor and prolong time to relapse. An informal analysis of the ECOG trial and an additional 11 clinical trials that enrolled a total of almost 4,100 patients showed the same thing: Many of the regimens that combined Taxol, Taxotere, Navelbine, or Gemzar with either cisplatin or carboplatin had similar effectiveness.

 

Choosing a treatment

 

How then do a physician and patient decide on a treatment plan? Corey Langer, MD, director of thoracic oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, says other health conditions such as diabetes or heart disease (called co-morbidities) may impact the decision as does overall health and fitness.

 

For instance, in individuals with pre-existing peripheral nerve damage, we are loath to consider Taxol at conventional doses. By the same token, pre-existing kidney disease or hearing loss will preclude cisplatin, Dr. Langer says.

Other side effects such as hair loss can also influence treatment choice. In the randomized trials mentioned above, 80% of those patients treated with Taxol/carboplatin experienced total or near-total hair loss. In comparison, only 10% of patients treated with Gemzar/cisplatin or Navelbine/cisplatin experienced significant hair loss. But Gemzar and Navelbine both require weekly clinic visits compared to Taxol and Taxotere, which only require a clinic visit every three weeks.

 

For patients who cannot tolerate one treatment, other options remain. Physicians continue to prefer the doublet that contains Taxol, Taxotere, Navelbine, or Gemzar with either cisplatin or carboplatin because the clinical trial data show effectiveness, but if treatment with cisplatin or carboplatin is not possible, regimens such as Taxol/gemcitabine or Taxotere/gemcitabine are effective and more tolerable than the platinum-based therapy.

 

The Older Patient

 

Age must also be taken into consideration when planning treatment.

 

Interestingly, although 58% of patients with lung cancer are over 70, the median age of the patients enrolled in most clinical trials is only 59. However, Dr. Langer says age alone is not a deterrent to treatment because elderly patients who are fit do as well or nearly as well as younger, fit patients.

 

Dr. Langer distinguishes between patients in their 70s who appear to tolerate chemotherapy reasonably well and those over 80 because, he says, the data are extraordinarily sparse on patients over 80.

The little data that exist suggests that they do considerably worse. We must also respect the potential for increased toxicity in older individuals, although we need to acknowledge that the fit elderly do as well as younger individuals from a therapeutic standpoint.

 

The elderly may also be restricted by the availability of caregivers, financial concerns, or by reluctance to pursue more aggressive treatment. And physicians who believe treatment will not be as successful in the elderly patient might treat less aggressively.

 

Yet, growing evidence shows there are feasible and successful treatment options for the elderly patient. A large Italian study compared chemotherapy with Navelbine to supportive care without chemotherapy in elderly lung cancer patients and determined that survival was prolonged in those who received chemotherapy.

 

A second trial conducted in Tennessee showed that Taxotere was able to induce tumor shrinkage in 26% of lung cancer patients who were elderly and had medical conditions that would have otherwise precluded treatment. This rate is approximately equal to that seen in other Taxotere trials in younger lung cancer patients.

 

Lastly, a large clinical trial recently compared chemotherapy with the combination of Gemzar and Navelbine to either Gemzar or Navelbine alone. Administration of two agents is the prevailing preference among lung cancer patients as a whole, but in this group of patients over age 70, Gemzar or Navelbine as single agents worked as well and had fewer side effects than the doublet.

 

Dr. Langer says the key to making treatment choices is fitness and potential for physical vulnerability. Frail patients are best served by single agents; the fit can tolerate combination regimens.

Since no one treatment regimen is suitable for every lung cancer patient, the patient and physician must consider medical history, overall health, age, and lifestyle.

 

Hope for Breaking the Plateau

 

The combination of Taxol/carboplatin is one of the most widely used regimens in the United States for patients with newly diagnosed advanced lung cancer, but many other drugs appear to have equal effectiveness for these patients. Frustrated, many physicians have termed this the therapeutic plateau, because although significant progress has been made, theyd like to see even greater strides.

 

Many physicians and patients are banking on a new class of therapeutics known as targeted therapies to break the plateau and take lung cancer treatment one step further. Among the most promising of these new agents are Iressa (gefitinib), Tarceva (erlotinib), Erbitux (cetuximab or C225), ABX-EGF, and Avastin (bevacizumab). It is hoped that these agents can either improve the effectiveness of chemotherapy or help patients for whom chemotherapy has failed.

 

When Gary Lougher was a teenager, he decided not to start smoking because he didnt want to risk developing lung cancer. He stayed true to that decision throughout his 24-year stint in the U.S. Navy. Ultimately, though, the career he loved brought on the disease he dreaded.

 

As a Navy electronics technician during the 1970s, I was frequently exposed to nuclear radiation, asbestos, and a variety of chemicals, says the 48-year-old from Chesapeake, Virginia, who has bronchoalveolar carcinoma, a rare form of lung cancer. The Navy has determined that my particular kind of cancer has been linked specifically to nuclear radiation exposure.

 

Once known as a disease plaguing only those who smoke, lung cancer is increasingly affecting nonsmokers as well. Bronchoalveolar carcinoma in particular is unique because 30% of patients affected with this subtype of lung cancer have never smoked. Other carcinogens, such as secondhand smoke, radon, and asbestos, play a role in the development of lung tumors.

 

When Lougher was diagnosed in 1998, his cancer had already spread to surrounding lymph nodes, causing severe chest pain. He had surgery to remove part of his lung, underwent radiation therapy, and was treated with three different chemotherapies. But nothing seemed to slow the disease.

 

I had terrible side effects, including complete hair loss, severe diarrhea to the point of dehydration, and extreme weakness, Lougher explains. I had reached the point where I couldnt even shower without my oxygen tank nearby. I thought I had about three months to live, so I called my family and asked them to visit me one last time.

 

Thats when Lougher heard about a new drug called Iressa (see sidebar) from an online lung cancer support group. He decided to try it.

I started taking Iressa in April 2001, and I saw miraculous effects overnight, he says. I literally skipped into the kitchen the next morning, amazing my family. I am very thankful for every extra day Ive been given to spend with my family and friends. Taking Iressa has made that possible for me.

 

 

 

 

New Hope With Targeted Therapies       

 

Iressa is taken in pill form and is the first drug available in the United States from a new class of anticancer drugs called selective epidermal growth factor receptor (EGFR) inhibitors, which target signaling pathways necessary to the growth and survival of cancer cells. By blocking these pathways, Iressa helps stop tumor growth. In phase II trials, Iressa reduced disease-related symptoms with relatively minor side effects in patients with NSCLC who had progressed after previous treatment.

 

NSCLC accounts for up to 80% of lung cancer cases, so finding an effective treatment is of utmost importance, says Roy Herbst, MD, PhD, chief of the section of thoracic medical oncology, M. D. Anderson Cancer Center, Houston.

In U.S. clinical trials, Iressa seems to have improved the quality of life for many patients. About 10% of the participants have experienced tumor shrinkage of 50% or more in large phase II studies with previously treated patients, he adds.

Dr. Herbst says Iressa is still effective as a single agent, and further studies will be needed to find other combinations that will enhance that effectiveness.

Tarceva is another EGFR inhibitor that is undergoing clinical trials in lung cancer. Three large trials of Tarceva, either by itself or in combination with chemotherapy, have completed accrual. Results should be available later this year.

 

Chandra Belani, MD, co-director of the Lung and Thoracic Program at the University of Pittsburgh Cancer Institute, is involved in clinical testing of ABX-EGF, another drug that, like Iressa, targets EGFRs. ABX-EGF, a fully human monoclonal antibody, is given by infusion.

 

ABX-EGF is well tolerated and produced relatively mild side effects such as rash and diarrhea in phase I trials, says Dr. Belani. Were now moving forward with phase II trials, testing ABX-EGF in combination with standard chemotherapy. Although we dont have all of the data yet, were optimistic about this drugs impact on lung cancer treatment.

 

Targretin® (bexarotene) is another novel agent being evaluated in combination with chemotherapy for lung cancer patients. In the United States, Targretin plus Taxol/carboplatin is under evaluation. Targretin, an oral agent that was first evaluated in lymphoma patients, showed some activity in lung cancer patients in phase I trials, leading to both the U.S. trial and one in Europe evaluating Targretin with Navelbine/cisplatin.

 

Avastin, another monoclonal antibody playing a significant role in novel lung cancer therapies, is known as an anti-VEGF because it has the potential to block vascular endothelial cell growth factors, one of the key proteins providing blood supply and nutrients to cancer cells, thereby stimulating tumor growth. In late June 2003, Avastin was given fast-track designation from the FDA for treatment of advanced colon cancer.

 

Side effects from the infusions tend to be mild, although earlier trials showed bleeding and blood clots as risk factors.

Avastin isnt a cure, says Alan Sandler, MD, medical director of thoracic oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee. But it may one day help us control lung cancer to the point where it becomes more of a chronic disease. Then we can concentrate on controlling problem symptoms while we continue to search for a cure.

 

Dr. Sandler says this is where clinical trials play a crucial role because they often provide better care with more individual attention from some of the best doctors, nurses, and technicians in the profession.

Patients sometimes tell me they want to participate in clinical trials to help save the lives of those who will have the disease in the future, Dr. Sandler remarks.

 

Thats a very noble thing to do, but I tell them to get involved to help themselves first. I encourage them to be selfish for a very simple reason: I want them to get better.

 

Editors note: Gary Lougher passed away Feb. 10, 2003. CURE is proud to honor his memory.

 

Treatment

As is true of many cancers, the treatment of lung cancer depends upon a variety of factors. The most important factors are the histopathologic (diseased tissue) type of tumor that is present and its stage. Once a lung cancer has been staged, the physician and patient can discuss treatment options. An individual then has a better idea of the value of different forms of therapy. Other factors that are taken into account include the person's general health, medical problems that may affect treatment (such as chemotherapy), and tumor characteristics.

 

The characteristics of the lung tumor help to separate individuals into two groups: (1) those who are at low risk of cancer recurrence and (2) those who are at high risk of cancer recurrence. Specific prognostic - disease-forecasting - factors place patients in either of these groups. In particular, the histopathologic groupings of small cell lung carcinoma (SCLC) versus non-small cell lung carcinoma (NSCLC) may be used to better predict a patient's prognosis and response to therapy.

 

Surgical resection, or cutting away, of the tumor generally is indicated for disease that has not spread beyond the lung. Such resection may be conducted using a variety of techniques. Thoracotomy - the opening of the chest wall for surgical procedures - and median sternotomy - surgery performed by cutting through the breastbone - are standard methods used for lung cancer surgery. Alternative approaches include anterior limited thoractomy (ALT), thoractomy performed on the frontal chest using a small incision; anterioraxillary thoracotomy (AAT), thoracotomy performed on the frontal chest near the underarm), and posterolateral thoracotomy (PLT) thoracotomy performed on the back/side region of the trunk. ALT, in particular, is less invasive than standard thoractomy - that is, it involves less disturbance of the body by incisions or other intrusive measures. ALT may result in less surgical blood loss, less postoperative drainage, and less postoperative pain than standard thoracotomy.

 

Recently, surgeons have developed other less invasive procedures for the removal of tumorous tissue. For example, video-assisted thoracoscopy (VAT), otherwise known as video-assisted thoracic surgery (VATS), uses a video camera to help visualize and operate upon the lung within the chest cavity. The surgical incisions made during VAT are much smaller than those needed for thoracotomy or sternotomy. However, some physicians caution that VAT does not allow complete lung examination to identify and remove metastases that are not detected by preoperative chest X-ray. VAT is perhaps most appropriate for Stage 1 and Stage 2 cancers that require lobectomy (surgical removal of a lung lobule) with lymphadenectomy (removal of one or more lymph nodes) and for peripheral (outer edge) lung tumors that can be removed by wedge resection. In such cases, follow-up is required to establish a long-term prognosis.

 

Computed tomography (CT) scans also have been added to VAT technology to improve lung cancer surgery. Experts have found that percutaneous (through the skin) CT-guided localization wires help to identify tumorous lung nodules. In this way, wires can be used to assist VAT in cases that need sublobectomy resection (partial removal of a lung lobe).

 

Unfortunately, surgical procedures may cause lymphocytopenia - low number of lymphocytes (white blood cells) in the blood - which is linked with shorter survival times among patients with advanced lung cancer. Lymphocytopenia may be related to a deficiency in interleukin-2 (IL-2), a hormone that controls the activity of T lymphocytes (thymus-dependent lymphocytes). Preoperative treatment with recombinant human interleukin-2 (rhIL-2) may help to prevent the lymphocyte decrease that occurs after surgery for operable lung cancer.

 

If the tumor is more aggressive and/or widespread, chemotherapy and radiotherapy (radiation therapy) also may be necessary. In addition to chemotherapy and radiotherapy, other treatments are now available for the management of lung cancer.

 

Photodynamic therapy  (PDT) may be especially useful for the care of persons with inoperable lung cancer. Photodynamic therapy begins with the injection of a light-activated drug (e.g., photofrin/polyhaematoporphyrin, lumin). Then, during bronchoscopy (examination of the airways using a flexible scope), the lung tumor is illuminated by a laser fiber that transmits light of a specific wavelength. At that time, the laser light is used to destroy the sensitized tumor tissue. Skin photosensitivity (light sensitivity) is a side effect of PDT. The curative potential of PDT is the most exciting aspect of this therapy in lung cancer patients whose tumors are occult (hidden, unseen) on chest X-ray. The tissue-sparing effects of PDT may be particularly important for individuals with limited lung function.

 

Electrosurgery Elecctrosurgery is surgery performed using a needle, bulb, or disk electrode, Nd-YAG laser therapy (neodymium-yttrium/argon laser that concentrates high-energy electromagnetic radiation to destroy tissue), cryotherapy (destruction of tissue using extreme cold), and brachytherapy (treatment with ionizing radiation) are additional tumor debulking, or size-reducing, techniques that may be performed during bronchoscopy. Such methods are especially useful for obstructive, inner cavity (intraluminal) lung tumors.

 

Radiotherapy (Radiation Therapy)

Radiotherapy - otherwise known as radiation therapy - is a treatment method that uses high-energy, ionizing radiation (e.g., gamma rays) to kill cancer cells. Ionizing radiation is produced by a number of radioactive substances, such as cobalt (60Co), radium (228Ra), iodine (131I), radon (221Rn), cesium (137Cs), phosphorus (32P), gold (198Au), iridium (192Ir), and yttrium (90Y). Radiotherapy may be applied to shrink a tumor that is later removed by surgery, to relieve symptoms, or to destroy malignant cells in a tumor that cannot be removed surgically.

 

Because cancer cells usually multiply faster than most bodily tissues, they are especially affected by radiation, which prevents cell division and the formation of DNA (deoxyribonucleic acid; human genetic material). Yet the bodily tissues that also divide rapidly - such as hair and skin - are particularly vulnerable to radiotherapy. The specific side effects of radiotherapy include hair loss and skin disorders (e.g., erythema, skin redness due to blood vessel congestion; puritis, itching; desquamation, sloughing-off of outer skin layers; pain; atrophy, shrinking; increased pigmentation; edema, swelling), as well as fetal damage, increased susceptibility to infection, tachycardia (increased heart rate), changes in taste perception, anorexia (loss of appetite), malaise, nausea, and vomiting.

Lung Cancer Cure: Natural, Safe, Effective & Scientifically Proven Results ---Cure for Lung Cancer!

Cancer Hope Reborn & Proven!

Two Canadian herbal remedies, after three years extensive clinical testing under the supervision of the Ministry of Health of China, were proven to be extremely effective and safe to unleash your healing power (see clinical data).

Are you looking for a truly effective cure for lung cancer? Look no further because you already have it. Your own immune system is the most powerful cancer curing machine!

However, you need the right tools to initiate your self-healing power. Getting the right tools is essential. They will assist your body's powerful healing functions which will help you correct your health problem.

Your immune system is the best medicine you have for many degenerative diseases, including lung cancer. Natural cancer treatments will not harm your body. Alternative medicine may provide a better solution. Building up your health naturally is what your body needs. However, you may be worried about alternative treatments because they do not have any scientific proof. You may not be sure whether they really work......whether they are really an effective natural lung cancer treatment......

If you are searching for an answer for your lung cancer, look no further. Your body already has it.

Surgery, Chemotherapy, Radiation ....... invasive treatments with serious side effects.

Alternative treatments --- no scientific proof of effectiveness. NOW, you can have a better choice!

Learn more about how CESSIAC & YUCCALIVE, these two time-tested and scientifically proven herbal products, can help you initiate your own cancer curing functions. These Canadian herbal formulas are exceptionally safe, fast, effective, and they are scientifically proven by extensive studies in China under the strict supervision of the Ministry of Health of China.

CESSIAC and YUCCALIVE are time tested and scientifically proven!

These two herbal formulas have a long history in North America. Originally passed down to us from the native Indians, there have been numerous reported cases showing wonderful positive results. From 1993-1996, the Ministry of Health of China appointed three of the most reputable hospitals in China to conduct scientifically controlled tests on these formulas as well as on their individual ingredients. The results stirred a lot of interest in China. The effectiveness of the combined use of these two formulas was clearly demonstrated. Extensive use in Hong Kong and North America also showed how the combined use of these two formulas could positively impact the immune system.

Knowledge will not help your condition.  Only action will.  No matter how powerful our products are, if you do not use them you will not get the benefits.  Still doubtful? Enter to win a free month supply of our CESSIAC and YUCCALIVE and see the results.

Powerful tools for you to unlock  your self-healing power. Strong evidence throughout the past 80 years. Clinically proven under strict supervision of  the Ministry of Health of China. Let your immune system  take care of your lung cancer!

Tests in China included toxicity test, tumor inhibition test, medicinal test, immunological test, and a large scale clinical test. Visit our "Clinical" page to learn more about all these tests.

These herbal formulas are now being manufactured in British Columbia, Canada under a GMP (Good manufacturing practice -- medicine manufacturing standards) environment.

The production is carefully monitored; the finished products are fully controlled and measured with the specifications and standards set up by the Chinese Ministry of Health. In other words, professional quality control ensures consistent & effective products.

Safe, fast, effective, and PROVEN! CESSIAC and YUCCALIVE are powerful tools to help your body release and enhance its self-healing function. These products are not just folklore remedies. These are scientifically proven and extensively tested formulas that really work by helping you build up your immune system. As a result, your self-healing power will start to work and will be able to correct many of your degenerative problems. The combined use of CESSIAC and YUCCALIVE will restore your internal environment and provide the proper conditions for your body to regain health.

Breast cancer, prostate cancer, colon cancer, lung cancer, ovarian cancer, leukemia, lymphoma, diabetes, arthritis, Alzheimer, Parkinson... they are just signals from your body. Treat your body instead of your symptoms. Rebuild your health instead of suppressing your immune system. What you need is just the right tools to unlock your own healing power.

(CESSIAC ®) Chinese "Kang Ji" means Foundation of Health 

(YUCCALIVE ®) Chinese "Yu Kang" means Health's Nourishment 

These North American native Indian herbal remedies were introduced into China, the herbal kingdom, in 1993.  There were several ingredients in the remedies that even the Chinese did not have any information on them.  At the requirement of the Ministry of Health of China, numerous tests and studies were conducted by three major hospitals in China.  These hospitals included the Beijing Chinese Medicine University East Gate Hospital, the People's Hospital of Gunagdong Province, and the Guangzhou City Cancer Hospital.  The tests and studies included medicinal test, toxicity test, immunological test, tumor inhibition test, and a 245 cases clinical study.  Import permits were finally granted in 1996 by the Ministry of Health of China for these two herbal formulas to be imported into China as the first ever non-traditional Chinese medicine for a Class A disease.  The reports here show the results of the tests and studies done in China.  It was based on these results that the effectiveness of these herbal formulas were confirmed and the import permits were granted.

Since the Ministry of Health of China recognizes herbs as powerful medicines and the Chinese has an organized set of regulations to control herbal medicines,  these two herbal formulas are treated as medicines in China.  However, the health regulatory bodies in North America (FDA & Health Canada) have different sets of regulations toward the use of herbs.  These formulas then shall not be promoted as "medicines" in North America nor any medical claims shall be made.  That is why we are very careful in releasing this information to the general public in order to avoid violation of any regulations.  The manufacturer in fact always emphasizes that the products are just powerful tools that can assist us to get rid of the wastes and toxins accumulated in our bodies.   Once our internal environments become clean again, our immune systems will function properly as they were designed to and our own healing power will be unlocked. 

Note:  CESSIAC ®& YUCCALIVE ® are registered trademarks of MPS International Marketing Inc., The Chinese Names "Kang Ji" and "Yu Kang" are registered trademarks of the MPS Group in China and Hong Kong and are also being registered in Canada.  "Kang Ji" and "Yu Kang" are the official names of the formulas used in the Chinese studies.

 

CESSIAC 

For every problem, there is always a solution.

For every health challenge, there is always a relief.

Now we have the chance to derive the benefits from this God-sent herbal mixture to revitalize our health.

CESSIAC® is now made in Canada under a GMP standard (medicine manufacturing) environment according to the specifications set by the Chinese Ministry of Health.

          

To enjoy better results, use together with YUCCALIVE®.

It is not just the ingredients that count.

               Ingredients:         Sheep Sorrel

                                       Burdock Root

                                       Slippery Elm

                                       Rhubarb Root

YUCCALIVE 

Healing should have no geographical or cultural boundaries.

The effectiveness of the treatment method used, the drugs or natural remedies taken, should be judged according to the final result on the user's health.

Yucca Schidigera has been used by the American Indians for thousands of years.

 To enjoy better result, use together with CESSIAC®.

It is not just the ingredients that count.

 

    Ingredients:

        Yucca Schidigera      Licorice Root

        Fennel Seed             Clove Buds

        Anise Seed               Cinnamon Bark

        Honey

ORDER INFORMATION:

CESSIAC Case 6 x 909ml CESSIAC US$168         

YUCCALIVE Case 6 x 909ml YUCCALIVE US$168               

Combo Pak Case

4 x 909ml CESSIAC

2 x 909ml YUCCALIVE

US$168

Each case weighs 22 lbs.  Shipping cost for North America is US$25. One Combo Pak case will last 21-25 days for people with serious conditions and 75-80 days for prevention purpose. 90-Day Satisfaction Guarantee

 

CESSIAC

According to naturopathic medicine and traditional Chinese medicine TCM, the degeneration of our body system is the main source of our chronic diseases. We continue to accumulate toxins in our body from our environment through food that we eat, water that we drink, air that we breathe, and stress that we create. We are suffering from the consequences of human race's "effort" in polluting our planet. There is no way that we can avoid the contact of chemicals in our food chain, carcinogenic agents in our water system, and disease-causing pollutants in the air that we breathe. These toxins are choking our body on the cellular level. Therefore our organs do not function properly, our immune system suppressed, and our total body function out of balance. Then we have cancer, MS, diabetes, arthritis, lupus, gall stones, hyperthyrodism, sleeping disorder, heart disease, stroke, high blood pressure, Alzheimer's disease, dementias, cirrhosis...... and we try to get rid of these symptoms by putting more poisons (man-made medication) into our body.

Getting rid of the toxins in our system is the first step we should take in order to correct the degenerative health conditions that we have. No matter how much nutrients we dump into our system, how positive our attitudes are, how much exercises we do, and how much we rest, if we do not unplug our system and flush out the toxins we have, the correction will not happen. Only by eliminating the toxins in our body, our immune system will resume its proper function. Our immune system is the best medicine that we have to fight against degenerative diseases. Detoxification is the key to unlock the door to supreme immune system, hence optimal health.

According to the Chinese studies, the CESSIAC formula is a powerful tool to do this. The Ojibway tribe in Ontario, Canada, had used a special herbal remedy for treating their ailments for hundreds of years. In 1922, Nurse Rene Caisse introduced the herbal remedy into the White society. Throughout the past seven decades, thousands of people in North America benefited from it. From 1993 to 1996, a group of Chinese herbal experts worked on the remedy extensively. Extensive studies were conducted in China under the strict supervision of the Ministry of Health of China. Specifications to determine the effectiveness of the herbal remedy were set and the original Ojibway formula was modified with the Chinese herbal wisdom. Now we have a much more potent and effective formula. This is CESSIAC - the Chinese improved Rene Caisse formula.

CESSIAC is now manufactured in British Columbia, Canada, according to the specifications set up by the Chinese herbal experts in the Ministry of Health of China after the extensive tests and studies were conducted in China. These specifications are also enforced by the Ministry of Health of China for the importation of the herbal remedy into China. The raw materials used for the manufacturing of the herbal remedy are selected under strict scrutiny and organic herbs are used whenever they can be obtained. The production is under a strict GMP (drug manufacturing) standard environment. The high quality standard warrants the greatest benefits that users can get from the herbal remedy.

The Chinese studies showed that CESSIAC serves as a powerful and effective tool to help us detoxify the toxins in our blood and in our cells. The powerful cleansing effect results in dramatic change in the users' health conditions. The herbal remedy will wake up the immune system and allow the body to function properly again.

 

Ingredients:

CESSIAC contains the same four herbs as in the old Ojibway remedy and Nurse Rene Caisse's formula. However, it has a different ratio mix of herbs and a different method of preparation. Thanks to the Chinese herbal experts: the result of the remedy is greatly amplified. The difference can be very obvious on people who have been using other similar products. No other similar products has gone through that many extensive scientific testing and no other similar products has a set of specifications established by top herbal experts of China to determine their quality and effectiveness.

Sheep Sorrel (Rumex acetosella)

Burdock Root (Arctium lappa)

Slippery Elm (Ulmus fulva)

Rhubarb Root (Rheum palmatum)

 

Results:

According to the Chinese studies, CESSIAC provides a powerful cleansing effect to our blood and cells. It greatly enhances the healing force of our immune system. It works magically with the liver, pancreas, and endocrine system. In the clinical studies in China and clinical applications in Hong Kong, users always took both CESSIAC and YUCCALIVE (a Yucca base product which is for cleansing the intestines) together. Both herbal products work perfectly together to give our body a complete cleansing.

In addition to its cleansing power, CESSIAC is also believed to be a very powerful antioxidant and contains a lot of plant enzymes with great therapeutic results.

Are You Facing a major health challenge?

Your immune system is the answer  --- it is the real CURE for your health problem!

 

There is no magic bullet!

No drugs, therapies, supplements, or surgeries alone can correct a major illness.  They may be able to alleviate or cover the symptoms temporarily.  However, for every illness, the final healing has to come from within us.  From a minor cut on the finger to a life-threatening disease such as cancer, our own immune system is the only answer.

Most of our degenerative diseases begin with the improper functioning of our immune systems.  The malfunction of the immune system in many times is due to the imbalance of nutrients in our bodies.  Under-supply and over-supply of nutrients cause some of our cells out of balance.  These cells will become unable to repair the damages they suffer due to metabolism and free radicals.  Without a proper source of a balanced nutrients, the cells will not be able to repair themselves.  If the imbalance is not corrected in time, the health problem will gradually become worse and will finally become untreatable.

 

If you are searching for an answer for a cure for your health problem, look no further.

Your body already has it.

It's YOUR IMMUNE SYSTEM

 

In order to put your immune system in action again, you must take a holistic approach.  Detoxification-Nutrients-Positive Attitude-Exercise-Rest are the five major factors that you have to pay attention to in order to rebuild your health.  There is no single treatment or health product that can provide you with all these five factors can bring you.  

Getting to and maintaining a healthy state is an educational process.  You have to educate yourself of why and how something can help you.  In this informational generation, you can easily collect information to help you make correct health decisions.

 

Let Our Powerful Food/Herb Combination Be Part of Your Health Rebuilding Program

Our products CESSIAC and YUCCALIVE has a long time origin from the North American native Indians.  The ingredients in these two products provide a large spectrum of nutrients that our bodies need in order to maintain a functional immune system.  The health benefits of the ingredients of CESSIAC and YUCCALIVE have been clearly demonstrated in the native Indian communities for thousands of years as well as in people who used these products in recent years.  They are real POWER FOODS.

 

CESSIAC ®

Ingredients:       

Sheep Sorrel

Burdock Root

Slippery Elm

Rhubarb Root           

YUCCALIVE ®   

Ingredients:

       Yucca Schidigera      Licorice Root

       Fennel Seed              Clove Buds

       Anise Seed               Cinnamon Bark

       Honey

New Approach To Lung Cancer Treatment

Jan. 13 Lung cancer is our deadliest cancer and often difficult to treat. Now researchers say, a new drug is showing real promise for certain patients. Dr. Dean Edell reports.

 

Watch this report

More recent stories...

 

When Elizabeth went for her annual checkup, she thought she was the picture of perfect health, but a routine x-ray showed a spot on her lung.

 

Elizabeth Aviles, lung cancer patient: "I had no symptoms, nothing, absolutely nothing, so I was quite surprised."

 

Elizabeth has non-small cell lung cancer. Treating the disease usually means rounds of chemotherapy delivered intravenously. But Elizabeth's oncologist suggested something new - a pill called Iressa taken once or twice a day.

 

Alex Adjei, M.D., medical oncologist: "It's a treatment that's convenient, it's taken by mouth, the side effect profile seems to be less than regular chemotherapy, so a patient's quality of life is going to be better."

 

Instead of killing all cells - like chemo does - Iressa specifically targets cancer cells. It's part of a new group of drugs called EGFR inhibitors. A tumor forms when normal cell growth is interrupted and cells divide uncontrollably. Iressa blocks the growth process.

 

Laeeq Ahmed, M.D., research oncologist: "It is not, at the present a homerun. But it is a very exciting development."

 

In phase 2 clinical trials, more than 50 percent of lung cancer patients taking Iressa had the disease stabilize. Elizabeth was one of them.

 

Elizabeth: "The Iressa had me cancer-free for about three months."

 

Experts say it's too early to tell what impact Iressa will have on survival rates. What is clear is that the pill is making a dramatic difference in a patient's quality of life.

 

One problem with Iressa is that it only works well in certain lung cancer patients. Doctors are trying to find the best way to predict which patients will respond. Iressa is also being investigated in head and neck cancer, as well as prostate cancer, breast and colorectal cancers.

 

New Results Published in the Journal of Clinical Oncology

January 8, 2004 - Wilmington, DE - New data published this week in the Journal of Clinical Oncology (JCO) highlight the first Phase II clinical trial of IRESSA® (gefitinib) Tablets in patients with recurrent glioblastoma. Glioblastoma is the most common of the primary malignant brain tumors and is one of the most challenging to treat effectively, with a 5-year survival rate of approximately 5 percent.

 

We continue to look for better treatments for those diagnosed with this lethal cancer, said Judith Ochs, MD, Senior Medical Director of Clinical Research for IRESSA at AstraZeneca.

 

The open-label, single-center Phase II trial included 57 patients with first recurrence of a glioblastoma who were previously treated with surgical resection, radiation, and usually chemotherapy. These patients underwent an open biopsy or resection at evaluation for confirmation of tumor recurrence.   Each patient received 500 mg of IRESSA orally, once daily.  Dose escalation to 750 mg and 1000 mg occurred if a patient received enzyme-inducing antiepileptic drugs or dexamethasone.

 

The primary endpoint of the study was 6-month progression-free survival, with secondary endpoint measurements of tumor response rate, event-free survival, overall survival, and drug toxicity. No patient had either complete response or partial response, and 31 patients had radiographic progressive disease (58.4%) within the first two months. In total, 51 of the 53 assessable patients eventually developed progressive disease, with two patients remaining on therapy at the time of manuscript preparation; 21 percent of patients (11 of 53) had measurable disease at treatment initiation. Seventeen percent of patients (nine of 53) underwent at least six 4-week cycles of IRESSA. The 6-month event-free survival was 13 percent (seven of 53) and the median duration of event-free survival was 8.1 weeks.  The median overall survival time from treatment initiation was 39.4 weeks.

 

Adverse events were generally mild to moderate (grade 1 or 2) and consisted mainly of skin reactions (60%) and diarrhea (40%). Other toxicities that were encountered that were felt to be possibly related to the use of IRESSA included conjunctivitis, onycholysis, anorexia, weight loss, and AST and ALT elevation. Drug-related toxicities were more frequent at higher doses.  Patient withdrawal caused by drug-related adverse events occurred in 6 percent (three of 53) of patients receiving 500-1000 mg/day of IRESSA. 

 

Glioblastoma represents approximately 20 percent of all primary tumors found in the brain.  Each year approximately 5 of every 100,000 individuals in the United States are diagnosed with glioblastoma. The disease is typically found in people 40 to 60 years of age and occurs slightly more often in males than in females.  Glioblastoma is considered an aggressive tumor; it usually recurs within 1-2 cm of the original tumor site.  While it may spread to surrounding tissue within the brain, it rarely spreads to other parts of the body. Due to its location in the brain, however, it is usually rapidly fatal.

Lung cancer now is the most common cancer-related cause of death among men and women. In 2002 there will be about 169,400 new cases of lung cancer in the U.S, among which, 154,900 will die, including 89,200 men and 65,700 women.

 The two main types of lung cancer are non-small cell lung cancer and small cell lung cancer. Small cell lung cancer is highly associated with smoking and grows and spreads quickly.

 Orthodox lung cancer treatment (surgery, radiation & chemotherapy) has showed, in some cases, potential in relieving symptoms and improving the patient's quality of life. But in most other cases, the death rate of surgery, the side effects of radiation and chemotherapy are always beyond that patients can tolerate.

Canelim Capsules, the medicine we recommended here, is the only Chinese anti-cancer medicine listed in Class A of the National Basic Insurance Catalog, China. It is of high efficiency in killing cancer cells, boosting immunity and thus reducing cancer body, inhibiting cancer growth and metastasis, alleviating clinical symptoms and pain, prolonging life expectancy and improving life quality. It fits for all stages of lung cancer, either be applied alone or in combination with standard treatments:

"          as forerunner of surgery to shrink the cancer, so that it is easier to be removed.

"          To be applied together with surgery, chemotherapy and radiation therapy.

"          as maintenance in the inermission of treatment or after surgery, or

"          as the main treatment when the cancer comes to a terminal stage that none of conventional treatments is applicable.

 For anyone who has radiation or chemotherapy or both, additional A-L Tonic Capsules is recommended

Canelim Capsules Permission No.           (1995)-zz-5772, #000313 Description    Capsule

Main Ingredients      Radix Curcume, Herba Agrimonia, Fructus Aurantii etc

Main function      

1. Kill the cancer cells and inhibit the growth of tumor, has significant therapeutic effect on common solid carcinoma

2. Strengthening body resistance, raising body immunologic function

3. Ideal complex effects:a. specially enhance sensitivity of anoxic cells to chemical medicine and radiotherapy. b. rapidly release the side effects of radiotherapy and chemotherapy.

4. Raising patient's living quality and prolonging patient's life

Therapeutic Range             

1. Lung cancer, gastric cancer, esophagus cancer etc

2. Lung cancers include small cell lung cancer, non-small cell lung cancer, squamous cell carcinoma of lung, pulmonary carcinoma, large cell lung cancer, etc.

Administration & Dosage 

take orally, 6cap*3 times/day, 33days/course generally, a total of 3 courses needed, long term useage encouraged.

Adverse Reactions            

1. No toxicity and side effect, can be used in a long term.

2. Slight stomach upset occasionally seen. No need to stop.

Stands on TCM Theory     

1. Resolve mass and swelling

2. Remove the phlegm and detoxicate

3. Promote blood circulation to stop pain

4. Exert tonic effect on the heart and strengthen the body

Animal Test         

1. Tumor inhibition--S180 tumor

2. Life extension--H22 tumor

3. Immune enhancement--S180 tumor

4. Pain relief

Clinical Reports  

A. 500 cases studied by the First Attached Hospital of the Fourth Millitary University in the last 20 years showed that this product can not only greatly relieve symptoms and improve life quality, but also disperse majore sufferings from malignant tumors, especially for those with pulmonary cancer. Follow-up survey of 22 patients with lung cancer, 6 lived over 15 years.

B. Review--therapeutic effects of Canelim Capsules on malignant tumors

C. A statistical data of 24771 patients with different types of cancers show that total effective rate varies from 53.2% to 89% respectively.

D. Clinical observation of Canelim Capsules combined with chemotherapy on 86 cases terminal stage primary lung cancer

Price      

RMB2088/course (100 cap*6 bottle for 33days), US$254     Buy now!

Disclaimer: This information is for educational purposes only, It is not to diagnose or treat your disease. If you do use the information contained on this web site without the approval of a health professional, you are prescribing for yourself, which is your constitutional right, but the author(s) and webmaster assume no responsibility.

Lung Cancer Survivor : I only Relied on Tian Xian Liquid Philippines, Mr. Sing Kio, 58

April 23, 1998 - Century Park Sheraton Hotel, Manila Philippines (Translated from Chinese)               

Last June 1991, there were nights while I was sleeping that I would cough very hard, and throw up phlegm. Like normal procedure, I took common western & chinese herbal medicines to cure my simple disease.

But, this did not solve the problem. I then consulted a physician named Doctor Ang. He's an old doctor and thus, have a lot of experience. After taking an X-RAY (Figure 1), the doctor noted a slight enlargement near my left lung as compared to a normal X-RAY (Figure 2). "This is a very suspicious area, you'll have to go get a CT-SCAN.", the doctor suggested. I hesitated to have my CT-SCAN and just asked the doctor to prescribe some medicine. He prescribed some antibiotics, but unfortunately, it didn't work. I visited him again, and he gave me another similar set of antibiotics, only the name have been changed. But still, nothing worked.

By November, I already have a fever.  After realizing that the medicine have no effect. I went to see another doctor, coincidentally, his name is Doctor Ang. The second doctor was older than the first and was very popular during the 1950's. After showing my previous X-RAY to the second doctor, he also gave me the same explanation and prescription. The medicine didn't work out again. The second time I went back to the doctor, he prescribed me a new set of antibiotics. This time around, the medicine didn't conform with my body and hence, I lost 8 pounds.

I took the medicine from November 11 to December 10, 1991. But, my fever worsen, my phlegm already contained blood, and my cough worsen. So, I went out to look for another doctor in a big hospital. This time around, the doctor (although named Doctor Ang again) was a young doctor. On December 10, 1991, the third doctor advised me to have another X-RAY and CT-SCAN. Two days later, I saw the result (Refer to Figure 3). The result was worse. The doctor didn't even believe that the man to whom the X-RAY belonged to was still alive.

X-RAY CONSULTATION REPORT :  Chinese General Hospital and Medical Center.  Case No. 360114.  Name : Sing Kio.   Referred by : Dr. R. Ngo.  Date : 12-10-91.  Clinical Data : CHEST.  Compared with the previous examination taken outside dated 11-11-91 shows interval progression of the atelectasis and infiltrates in the left lung base.   The right lung is clear.  Heart is not enlarged.  Diaphragm is intact.   IMPRESSION: Atelectasis and pneumonia infiltrates, left lung base showing interval progression.  Possibility of this being secondary to hilar compression cannot be ruled out. 

By : E. Dy M.D. (Radiologist)

The doctor said that the tumor is way too close to the heart. Hence, surgery, chemotheraphy, cobalt therapy is not possible even if the tumor was benign or malignant. To me, it was more of like a death sentence.

The CT-SCAN results (Refer to Figure 4 & 5) showed that the tumor was 9.4 cm X 6.4 cm. On that same day, the doctor didn't want to prescribe any medicine and advised me to consult a TEMT specialist to find out if there is something wrong with my throat. Result showed that there is an inflammation in my esophagus. The TEMT specialist recommended to perform a surgery within three days. I hesitated because I think there was nothing wrong with my throat (I had voice, I can eat, etc).

CT-SCAN details : Chinese General Hospital & Medical Center, Section of Computed Tomography. Name : Sing Kio. Age : 58. CT No. : 91-1870.  Referred by : Dr. R. Ngo. Date : 12-20-91.

Consultation Report : C.T. SCAN OF THE CHEST.  Contrast study of the chest shows a huge pulmonary mass in the left lower lobe measuring 9.4 X 6.4 cm.   This is attached to the hilum and pleura.  Nodular densities are seen in the hilum.  Acinar infiltrates are noted in the left upper lobe.  Fibrotic densities are seen in both apices.  The heart is lightly enlarged.  No lytic changes demonstrated. IMPRESSION:  Pulmonary mass, left lower lobe, malignancy is highly considered.  Attachment to the hilum and pleura is demonstrated.   Left hilar lymphadenopathy.  Fibrosis, both apices.

By : Cesar S. Co. M.D.

After that, the doctor advised to me to go back after 2 days to withdraw and analyze some liquids from my backbone. I went back and the doctor withdrew some liquid from my backbone using a large needle. Result showed that I was cancer negative. The doctor thought that he didn't place the needle at the correct location, thus, he tried again with a second needle. Result also showed that I didn't have cancer. He immediately congratulated me because according to his findings, I didn't have cancer. To further confirm his findings, he suggested that a tube should be inserted through my nose to pull out some more liquids. I refused to do so. Still, the doctor doesn't want to prescribe any medicine because the disease was still unknown.

I went to look for another doctor. His name is Dr. Tan. He also said the same thing as what Doctor Ang claimed since they got the same education. He asked me to go to a Filipino hospital to withdraw some more liquids.

I went to the Filipino hospital. He inserted a tube to my mouth for five times and pulled out some more liquids from my lungs for analysis.

After three days, it was found out that I had malignant tumor. The doctor said that I can't be operated on, nor use chemotherapy nor cobalt therapy since it was near my heart. Thus, I don't have any other alternative except to take Chinese medicine.

X-RAY CONSULTATION REPORT :  Chinese General Hospital and Medical Center.  Case No. 360114.  Name : Sing Kio.   Referred by : Dr. R. Ngo.  Date : 2-15-92.  Clinical Data : CHEST.  Compared with the previous examination dated 12-10-91 shows marked interval decrease in the size of the atelectatic segment previously noted along the left paracardiacarea. The rest of the lungs remain clear except for some pulmonary scarring in the left apex. The heart is not enlarged. Costrophrenic angles are well-defined.

By : T.U. Pastrana M.D. (Radiologist)

At that time, someone recommended the use of some basic Chinese medicine. Nothing changed in 20 days. Someone then recommended Tian Xian Liquid. After taking Tian Xian Liquid from January 10 to the end of February 1992 (approximately a month and a half), I had another X-RAY (Refer to Figure 6). The doctor said that the results was much better than the previous one (Refer to Figure 3), but still, this was a serious condition. My fever and cough improved, and vanished eventually.

Analysis of X-RAY:  Name : Sing Kio.   Age : 58.  X-Ray No. : 5619.  Date : 6-29-92.

Examination : CHEST.  Examination of the chest shows the heart to be normal in size.  The aorta is slightly dilated.  Blunting of the left costophrenic sulcus is noted.  Apical pleural thickening is noted on the right.   Minimal fibrosis is noted in both upper lung fields, more on the right.  The finding appears to be inactive Koch's lesion.  Comparison with previous study will be of help.  Minimal fibrosis is also seen at the left base and could be due to residual change from previous pneumonia.

Summary : Examination of the chest shows minimal scar, both upper lung fields, appears to be inactive Koch's lesion.  Minimal fibrosis at the left base is also noted.

By : Lorna S. Yiu Yap, M.D.  Diplomate, American Board of Radiology and Nuclear Medicine.  645 Condesa Street, Binondo, Manila.

Along with Tian Xian Liquid, I also take fruit and vegetable juices (half slice carrots, apple, one third of a cucumber, long celery, 2-3 leaves of lettuce, sugar beet). After extracting the juices, I drank 3 glasses per day. I continued to take the Tian Xian Liquid until June (1992) before I had another X-RAY. My fever and cough got better. I took another X-RAY(Figure 7) showed that there was nothing wrong with me. I took the X-RAY on a commercial firm, not in the hospital. My tumor has vanished. The doctor said that it looked like a dry scar of tuberculosis. Then, I stopped taking the Tian Xian Liquid until now.

Sonographic/Radiographic Report :  ACCUVISION DIAGNOSTIC CENTER, INC.  Name : Sing Kio.  Date : 03/09/1998.   File No. : 980645.  Sonographic/Radiographic Report : Chest X-Ray :   Fibrohazed infiltrates noted in both upper lung fields.  Rest of the lungs are clear.  Hear and the rest of the chest findings are unremarkable.  Impression: MINIMAL : PTB. BOTH UPPER LOBES, ACTIVITY UNDETERMINED.

By : Ma. Teresa D. Fontillas. M.D.

Last month (March 1998), I took another X-RAY (Refer to Figure 8). The X-RAY further confirmed that there is nothing wrong with me.

Recently, I have been diagnosed with colon cancer. So, in April 1998, I started taking up the Tian Xian Liquid again. The doctor advised me to undergo operation for my colon cancer. I refused and wanted to rely only on the Tian Xian Liquid. I hope by next year, I could be here again and testify to the wonders of Tian Xian Liquid.

Tian Xian Liquid

What is Tian Xian Liquid?

China No. 1 Tian Xian Liquid is the latest contribution of the International Rehabilitation of Cancer Association to all cancer patients in the world.  It represents a new breakthrough in mans struggle against cancer and is yet the best news for cancer patients.

The clinical experiments conducted on over more than 10,000 cancer patients in over 20 nations proved that the latest discovery of a Chinese medical researcher, Wang Zhen Guos China No. 1 Tian Xian Liquid has an efficacy rate of 80.7%.  This is especially true for cancer patients in the middle or late stages of illness.  This treatment is more effective when compared against other anti-carcinogens. (Please refer to the life stories of the cancer survivors).

This product was awarded by the State Ministry of Health and the State Medical Administration of China.  Some of its achievements include: The Highest Honors in the 38th World Eureka Invention Expo, including the Award for the Worlds Best Individual Invention, Medal of Honor from the King of Belgium, the Generals Medal and the Knights Medal. (Full details on his awards and recognition can be found in the Wang Zhen Guo awards gallery).

Tian Xian Liquid is made with purely natural substances with no trace of any chemical composition. It has anti-oxidant qualities scavenging for harmful free radicals. It is non-toxic. It increases the anti-cancer function of the bodys defense system. Therefore, stimulating and strengthening the immune systems anti-cancer function of the human body and inhibits the tumor growth. (See the Ingredients of Tianxian Liquid).

Tian Xian Liquid comes in 10cc vials and 280cc bottles for oral consumption.  Each course lasts 28 days.  The best time to take the dosage are 9 am, 3pm, 9pm, 3am, 10cc consumed each time. A total of 40cc is to be taken per day.  It can also be taken as a health drink (10cc per day) for the prevention of cancer.  (Details can be found in the Tianxian product information).

After taking the Tian Xian Liquid, conditions of hair loss, falling teeth, insomnia, anemia, etc., will be minimize.  Clinical experiments showed that significant results will be achieved after continuous dosage from 7 to 21 days.  After taking 4 to 6 courses, the cancerous cells in the human body will be under control.  They may cease to multiply rapidly and at times diminishes.  Thus, extending the life span of the patients and eliminating the threat of death.  It is necessary to avoid ingesting or exposure to carcinogenic substances, such as insecticides, pesticides, herbicides, nitrosamines, etc.

The Tian Xian (pronounced "Dianne Sean") products are herbal dietary supplements. The active herbal ingredients aims to control, inhibit and destroy cancer cells.  It's function is complementary to that of western therapies.

Testimonials of cancer survivors are from USA, Japan, Hong Kong, India, China, Philippines, Taiwan, Thailand, and Malaysia.  The list of testimonials are added regularly.

Two books were already published detailing how Tian Xian was invented, it's function and numerous cancer survivors stories.  The publications, beside English, are available in Chinese, Japanese, and Korean.

INDICATION

All kinds of cancer, the curative effect will be better if matched with Tian Xian Capsule and Tian Xian Suppository.

APPLICATION AND DOSAGE

In the first two months, oral administration, 10 c.c. 6 times daily, 6 and 9 o'clock in the morning, 12 o'clock in the noon, 3,6, and 9 o'clock in the afternoon. From the beginning of the third month (or the state of illness has been improved) oral administration, 10 c.c. 4 times daily, 9 o'clock in the morning 3 o'clock in the afternoon, 9 o'clock in the evening and 3 o'clock before dawn.

PRICE

US$890 (For 28 days treatment)

MAJOR FUNCTIONS

1. BLOCK CANCER CELLS

The contents of China No. 1 Tian Xian Liquid block the growth and multiplication cancer cells.

                To block the multiplication of cancer cells at a certain stage and thereby to kill them.

                To stop cancer cells breathing at the metabolism.

                To damage cancer cells and let them dissolve.

[Raw Medicines that block cancer cells growth] : Rhizoma Arisaematis, Rhizoma Curcumae, Radix Aconiti, Radix Aucklandiae, Radix Scrophulariae, Resina Garciniae, Sophora Alopecuroides, Herba Rabdosiae,Rubescentis.

2. ADJUST METABOLISM

To change all kinds of metabolisms that cancer cells require and thereby to suppress their multiplication. To improve the body invaded by cancer cells, to improve immunity against cancer cells, and thereby to suppress the multiplication of cancer cells.

[Raw Medicines that adjust metabolism] : Black Nightshade, Solanum Lyratum Thunb, Herba Sarcandrae, Radix Angelicae, Sincensis, Radix Salviae Miltiorrhizae, tulip.

3. IMPROVE IMMUNITY

To suppress cancer cell multiplication and to produce immunity, to control easy-to-increase environment, and to promote killer cell activities.

[Raw Medicines that improves immunity] : Radix Rehmanniae, fungi, Radix Acanthopanacis Senticosi, Radix Astragali, Ginseng, Poria Polysaccharide, Ginsen Soapgenein, Radix Astragali Polysaccharide, Radix Trichosanthis.

4. MICROELEMENT EFFECT

To improve the physiological aspect of the body through microelement activities, to promote genes activities, and to kill cancer cells.

(1) Selenium

To suppress cancer cells entering to genes; to suppress cancer cells in liver, and to block cancer cells from split at the middle stage.

(2) Germanium

To promote the excretion of lymph soluble substance II and interference enzyme I, to stimulate parasites to resist cancer cells, and subsequently to suppress tumor growth and spread.

LABORATORY TESTS RESULTS

With a view to understand the effect of Tian Xian Liquid in an objective and accurate way, Taipei FRC Biology Study Center carried out experiments to have further scientific verification of Tian Xian Liquid.  The experiments lasted for two years under 15 items of experimental topics and in the name of FRC001 (the laboratories not being aware of Tian Xian Liquid for the sake of fairness) and were designed in 4 main directives.  The experiment results are briefly described as follows.  Detailed experimental contents are also available for reference to the academe:

EXPERIMENTS ON REMOVAL OF FREE RADICAL

Tian Xian Liquid is able to effectively remove different free radicals

                can remove superoxide free radical, with clearance capacity of 300,000 units of SOD activity per c.c.

                can remove free radical generated by white blood cells, which vitamin E fails to effectuate

                can remove hydroxyl free radical, which vitamin E fails to effectuate

                capacity to remove lipide peroxide is much stronger than that of vitamin E

TOXICOLOGY EXPERIMENTS

From animal experiments to mice, Tian Xian Liquid was able to pass stringent acute toxicity test, micro-nuclear of bone marrow cell test, sperm distortion test and Ames test respectively.

IMMUNIZATION FUNCTION TESTS

Passing of animal experiments on mice, it was individually proven that:

                Tian Xian Liquid may increase the phagocytosis of macrophage

                Greatly strengthened lymphatic conversion for the spleen

                It raised the serum homolysis reaction and anti-host reaction, indicating significant benefits to immunization

INHIBITION EFFECT ON TUMOUR

As evidenced in a test on mice in sarcoma and hepatocele, inhibition effect shown was not inferior to chemical (5-Fu) and also quantum effect reaction was observed, i.e. larger is dosage better is the inhibition effect, which was greatly superious when comparing to reference group of glossy ganoderma and green algaes, etc.

The above 4 groups of experiments indicated that Tian Xian Liquid has passed the fundamental scientific tests in general.

INGREDIENTS

Radix Ginseng                                                         10%

Margarita                                                                 2.5%

Radix Astragalt                                                       10%

Borneolum Syntheicum                                           2.5%

Rhizoma Atractylodis Macrocephalae    5%

Radix Trichosanthis                                                                5%

Clematis Root                                                          5%

Heyotis Diffuse Wild                                                                15%

Solanum Nigrum L.                                                  5%

Indigot Naturalis                                                       15%

Ligustrum Lucidum AIT                                            2.5%

Radix Glycyrrhizae                                                 2.5%

Polyporus                                                                                10%

Pei Ursi                                                                    5%

Pogostemon Cablin                                                  5%

The following are some of the major components of the Tian Xian Liqiud and their respective effects in the body.  They are:

                Rhizoma Atractylodis Macrocephalae - It is refined from the stems and roots of Rhizoma Atractylodis, and is an aroma, stomachics and has diuresis effect.

                Radix Glycyrrhizae - It is refined from the roots, root skin, stems of liquorice, and has the effect of immunity, inhibition, relieving cough and phlegm removing.

                Radix Ginseng - It is refined from medicinal ginseng root and has the effects of stomach strengthening, stomach support and nourishment.

                Radix Trichosanthis - It is refined from the roots of tang wu gua and has anti-tumor and anti-bacteria effects.

                Radix Clematidis - It is refined from the roots of radix clematidis, and has pain relief and anti-cancer effects to digestive organs.

Tian Xian complements Western Medicine Treatment

Western cancer treatment has been in the forefront with it's surgery, chemo and radiation therapies. The concept of Chinese natural and herbal supplements emphasizes on the universal improvement of the immune system. Regulating the physiology enabling the cells to repair, regenerate and restore functions.

Tian Xian Liquid is the latest contribution of the International Rehabilitation of Cancer Association to all cancer patients in the world.  It represents a new breakthrough in man's struggle against cancer and is yet the best news for cancer patients.

The clinical experiments conducted on over more than 10,000 cancer patients in over 20 nations proved that the latest discovery of a Chinese medical researcher, Wang Zhen Guo's China No. 1 Tian Xian Liquid has an efficacy rate of 80.7%.  This is especially true for cancer patients in the middle or late stages of illness.  This treatment is more effective when compared against other anti-carcinogens. (Read more...)

WARNING:     We found counterfeits of Tian Xian Liquid present in several countries.  Please make sure that you buy the genuine product to ensure that you get the full effectivity of the medicine.  Contact us at the cancer hotline to confirm your local distributor.

NEWS: "Thailand Cancer Patient bought a Fake Tian Xian Liquid"

Warning on Counterfeits

We found out that many customers were able to buy counterfeits/fake products of Tian Xian Products in Hong Kong, Taiwan, Philippines, China, Japan, USA, and South East Asian countries.

We have invested on the development of a new package to combat against counterfeits. The design and the materials of the new packaging focuses on the presentation, convenience, safety and environmental protection.

The Lymph Tumor was Reduced by Tian Xian Liquid

I went to the hospital for a throat problem. The doctor said it was just a minor inflammation and he gave me some antibiotics.

However, the problem did not go away and since I needed to take care of my children, I just lived with it.

In September 1995, my neck began itching. I continued to scratch it and it began bleeding uncontrollably.

I rushed to the hospital and I was diagnosed with lymph cancer. Surgery followed the next month to remove two lymph tumors in three areas.

The doctor had to leave one of them as it was very close to the main artery.

We then learned about Tian Xian Liquid on the Internet, so we went to a drugstore in Bangkok to buy some.

Although I recovered a bit after using it, the pain increased severely. The condition got worse and I could still feel the depression.

One day I was able to browse through an advertisement of Tian Xian Liquid in the newspaper.  I compared the picture with the Tian Xian Liquid I recently bought, they were DIFFERENT! The Tian Xian Liquid I bought was fake! According to the news, there are so many counterfeits in the market.

I immediately ordered a new set of Tian Xian Liquid from a verified distributor.  Certainly, the effect of the authentic product was true.

My pain disappeared in a month, and after 6 months, the tumor was much smaller. I think it maybe the effect of both the chemotherapy and Tian Xian Liquid.

Just when I thought I could stop using it and rely on mere chemotherapy, I immediately lost my energy, my condition worsened, and the pain returned. Examinations showed that the tumor grew back, so I immediately started using Tian Xian Liquid again.

Now, I will never stop using it until I am sure that it is completely gone. The lymph tumor reduced to the point that I can hardly feel it. (Editor's Note: It is advised to take Tian Xian Liquid continually for a period of time, even in smaller dosage, as to prevent any recurrence)

Ms. Ma Mi Yu (46, Thailand)

Lung Cancer Survivor : Forever Grateful to Tian Xian Liquid

Ms. Watanabe Yuki (58, Japan)

I began coughing severely in November 1997 and I thought it was just a flu. I went to the hospital and they prescribed some cough medicine.  But still, coughing did not stop.

 After two weeks, I had an X-ray examination and it showed the accumulation of liquid in my lung. It was the cause of my cough. They were able to drain 4.5 liters of the liquid.

The severe cough recurred in April 1998, and water accumulation in my lung was confirmed.  After draining the water in the left lung, I thought I could go home. But water began to accumulate in the right lung as well. I had another operation and they injected medicine to my lungs to prevent further water accumulation.

However, my body rejected the medication and I suffered a high fever and had difficulty breathing. I already felt that my life was in jeopardy. The treatment for the right lung was suspended and the cough still wouldn't go away. Then, I lost my appetite. The cough grew worse after I went home.

It was even difficult for me to climb the stairs. I suffered greatly from the severe coughing during the three weeks at home. Then I went back to the hospital again.

The final test results on July 15 confirmed lung cancer. The sever cough made it difficult for me to speak, breathe, and walk, so I was bedridden. Fortunately, the patient beside me told me about Tian Xian Liquid.

I began taking 4 bottles a day (1 bottle = 10cc). In just three days, the severe cough was slightly relieved. I even had enough strength to walk to the toilet.

On September 13, I was relying on Tian Xian Liquid to improve my health so I could attend my daughter's upcoming wedding. Starting September 23, the doctors placed me on the anti cancer drip treatment. Many people did warned me about the severe side effects of the treatment.

My dream came true, the doctor allowed me to leave the hospital on October 15 and I was able to attend my daughter's wedding.

A follow-up X-ray examination showed that the lung cancer had disappeared, and there was no more water accumulation.

Lung Cancer Survivor : I Went to Work Right After Recovery

Mr. Yamdad Kimihiko (41, Japan)

(Wife speaking): "My husband received a surgery for thyroid cancer in November 1983. In 1992, it was revealed that the cancer had spread to his lungs, brain and neck.

Surgery followed, however, it was simply impossible to remove the cancer cells as it has already infected both lungs. The doctor told me that my husband could only live for 3 to 4 years more.

Since 1995, he was able to gain back some energy, but he lost his voice sometime during winter. February 1996, blood was discovered in his phlegm and he was then confined in the hospital.

I kept thinking of other ways to help my husband.  I then remembered Tian Xian Liquid, so I quickly looked into the details. After discovering that the rate of effectiveness of Tian Xian Liquid was 80%, I decided to place all of my hope on it.

My husband had no faith in this medicine and he simply refused to try any Chinese medicine as he already had a lot of it.  Tian Xian Liquid became my last hope, so I really urged him to try this treatment.

Finally, he agreed and started to take eight bottles a day during his stay in the hospital (1 bottle = 10cc).  Noticeably, his condition began to improve and we were able to leave the hospital.

After 10 days of continuous usage, the bloody phlegm ceased, chest pain then disappeared after another week.  He regained both his voice and his energy and he was able to went back to work very soon. Although the cancer is still there, his condition is very stable."  (Note: No recent news yet about the status of Mr. Kimihiko's cancer)

Lung Cancer Survivor : I can now say that Tian Xian Liquid is Really Effective

Ms. Ishikawa Hideko (67, Japan)

(Husband speaking) My wife was diagnosed with lung cancer in July 1997 and according to the doctor, surgery was not possible.

She underwent chemotherapy and radiotherapy treatment.  The doctor then said that she had no more than a year to live.

After undergoing stage four chemotherapy in October, my wife grew weaker from the side effects to the extent that she could not withstand it.  Approximately 20% of the cancer was still left.

Radiotherapy treatment was resumed in late October when there were signs of recurrence. The therapy continued until December, however, the cancer was still there.

Her condition improved and she was released from the hospital late December. In May 1998, an examination showed cancer cells had already spread to her brain. She was hospitalized immediately to receive chemotherapy and radiotherapy treatment.

After the treatment (June), the cancer was still in her lung and brain. In consideration of my wife's physical condition, the doctor told us that no more therapy should be given. In other words, it was hopeless.

We learned about Tian Xian Liquid from a news report and I immediately got into the details. After a quick order, I gave my wife 2 bottles (1 bottle = 10cc) a day.  The reason why I gave her only half of the standard dosage was because she suffered from gastritis which resulted from building pressure.

I increased the dosage to four bottles in June and her stomach pain receded.

An examination in July examination concluded that her lung cancer was still present but the brain cancer had disappeared. Frankly speaking, China No. 1 Tian Xian Liquid was not the only medication we had tried. For my wife, I had tried almost everything, but the result was in vain.

China No. 1 Tian Xian Liquid is really amazing: it destroy and inhibit the growth of cancer. Based on what happened to my wife, I can now say that Tian Xian Liquid is really effective.

After a month or so, we were really surprised to find out that the cancer on her brain has already disappeared.

To date, the brain cancer is gone, but the lung cancer is still there (Editor's note: No recent news about the status of the lung cancer).

We still continue to use Tian Xian Liquid to prevent the regression of the cancer and to improve energy.  Starting August, we also included Tian Xian Capsule No. 3 to her medication.

She left the hospital in mid August and we took the doctor's advice to use stomach medication in combination with China No. 1 Tian Xian products.

I thank Tian Xian for saving the life of my wife!

A Soldier's Experience with Lung Cancer

Mr. Jian Yong Guang (70, China)

A medical check up in April 1995 confirmed that I have stage 2 lung cancer. Immediate surgery was necessary or I would not live longer than 5 years, the doctor said.

The news was so sudden that no one in the family could accept the reality. I jog for 10 kilometers daily to keep my health in top condition and I do have regular medical check ups.

I was a soldier before and I was never afraid to die. But when I learned that I have cancer, I kept asking, "Why me?"  There were no apparent symptoms at all.

I was then hospitalized and underwent surgery in May. Although they removed a part of my left lung, the surgery did not completely remove the cancer. The doctor then advised me to undergo chemotherapy to prevent it from spreading.

I refused, not because I'm afraid of death, but because I prefer to just wait for my time than undergo such treatment.

Later, I realized that I can accept death, but I can never surrender to cancer. My condition grew worse after the surgery.  The wounds hurt badly and a lump was developed.  I lost my energy, appetite, and weight.

Then I heard that my friend's wife (who had cancer before) was cured by a Chinese medicine, so I quickly looked into it. She explained the details of Tian Xian Liquid to me and because of her acquaintance with Mr. Wang, she could ask him about my condition directly.

Mr. Wang encouraged me, "Don't feel hopeless, you can be cured!" He also sent me instructions on how to use Tian Xian Liquid and I began taking the treatment immediately.

The pain went away after using it for just a short time, but I began itching and had diarrhea for 2 months.

Honestly, I was beginning to doubt the efficiency of Tian Xian Liquid. But, according to Mr. Wang, the condition I was in was normal and I did trust his opinion.

An examination seven months after the surgery showed that the cancer cells have disappeared and there was nothing wrong with me. I still use Tian Xian Liquid and I enjoy a happy and healthy life.  (Editor's Note: Mr. Jian still take Tian Xian Liquid in smaller dosage so as to prevent any recurrence)          

Lung Cancer Survivor : I Regained my Life Through the Internet

Mr. Liu Wai (55, Hong Kong)

I am a healthy person and I just can't believe that I have lung cancer. A medical checkup because of excessive cough revealed this reality in September 1996. I underwent surgery only because I don't have any other choice.

They placed me on radiotherapy and chemotherapy treatment. I almost lost all of my hair because of the side effects, but, the doctor still continued both therapies.

My son then learned about Tian Xian Liquid from the Internet. Since the doctors do not recognize Chinese medicine, I have to use it secretly.

It was expensive to maintain both therapies at the same time so I asked the doctor to stop the chemotherapy treatment for a while. I still continued taking Tian Xian Liquid. My condition grew better and my hair began to grow again.

I told my doctor about my secret only after when I stopped coughing, but he had already suspected it even from the start. It was difficult for him to approve it.

The miracle was brought by from Tian Xian Liquid in combination with chemotherapy, and radiotherapy treatment. I began using Tian Xian suppository in June 1998 with excellent results.

The lung cancer receded and I went back to work. My overall condition is getting tremendously better. To relieve the pain caused by the wounds from the surgery, I also use Tian Xian Plaster.

My inspiration to get well is because of my family's well-being. The doctor said the tumor condition was stable and I only need to have a monthly checkup.

Later, I also found out that I was the only one who survived cancer in that hospital among the others that were confined during the time that I was there.

Thanks to Tian Xian Liquid for saving my life. I would like to add that Chinese people should not discriminate Chinese medicine. When it is used in conjunction with western medicine, the effective rate is also increased.

I started smoking when I was ten years old and lung cancer seemed unavoidable. Because of what I went through, I'm able to quit the smoking habit!

After using Tian Xian Liquid for 1 year, the Lung Cancer Completely Disappeared

Mr. Zhu Yu Lan (49, China)

On December 3, 1995, I started to experience fever, cough, and chest pains.  Also, blood was present in my phlegm.

Medical checkups concluded that there was a 3 x 4 cm tumor in my left lung and cancer cells were also found in my phlegm.

I received radiotherapy treatment at the hospital, but, I've to admit that it was not effective. I left the hospital on February 8. I was very anxious at this time.

In July 1996, a friend of mine (who just recovered from stomach cancer using Tian Xian Liquid) introduced this medicine.

I started with the Tian Xian treatment only after two months.  Since then,  the symptoms were relieved and the tumor was reduced in size to 2x3 cm.

I continued using it and an X-ray examination in August 1997 showed that the cancer was completely gone. The CEA was also negative. Also, there was no sign of recurrence.

In less than 5 Months the Tumor Disappeared and I'm back to Normal

Mr. Wang Zhou Hong (63, Malaysia)

I had several examinations (including X-ray) in March '97 and it concluded that I have lung cancer. They found a benign 3 x 2cm tumor.

The necessity of surgery was dependent on the results of further examinations. I remembered that surgery is not good for old people like me, so I only took medicine.

In May, my son learned from the Internet that Mr. Wang (Inventor of Tian Xian Liquid) was coming to Malaysia to give a free consultation.  I went to see him, he immediately confirmed that I have lung cancer and prescribed a one month Tian Xian treatment program which consisted of Tian Xian Liquid, Capsule, and Plaster.

An checkup in June showed that the tumor reduced by half. The effect is truly amazing. Then an examination in October 25, showed that it was completely gone.

I was tremendously happy. It was Tian Xian Liquid that took me away from the horror of death and pain. Now, the tumor is gone and I still continue to use Tian Xian Liquid to prevent any recurrence. An examination in March 1998 reconfirmed that everything is normal.

Lung Cancer Survivor : I only Relied on Tian Xian Liquid

Mr. Sing Kio (58, Philippines)

April 23, 1998 - Century Park Sheraton Hotel, Manila Philippines (Translated from Chinese)

Good Day to Everyone. Today, I am here to share on how the Tian Xian Liquid cured my cancer. First things first, I would like to make known that I don't have any relation with Professor Wang Zhen Guo (Inventor of Tian Xian Products) nor Mr. Manuel Kiok (General Manager of Green & Gold International Exports).

I would also like to say that it is not Professor Wang nor Mr. Kiok who asked me to share. In fact, I volunteered myself. My primary motive in testifying here today is to hear the lecture of Wang Zhen Guo on Cancer. Secondly, I wish to personally thank Professor Wang Zhen Guo for his invention (China No. 1 Tian Xian Liquid) which cured my cancer disease.               

Let me tell you how I was able to come to speak before you today. Sometime ago, I saw an advertisment of the Tian Xian Liquid and the Anti-Cancer Seminar (April 23, 1998) in a Chinese newspaper. I decided to call up the office of the distributor (Green & Gold International Exports). I was able to talk to Mr. Kiok personally. Eventually, I told him that I was cured of cancer 7 years ago due to my intake of the Tian Xian Liquid. I said I could share my testimony on the lecture day provided that my transportation should be met.

Before I continue, I would like to testify that I wasn't able to undergo any surgery, chemotheraphy, cobalt therapy or any other solution/medicine due to the position of the cancer (near my heart).  I was left with no option but to depend on Chinese herbal medicine. (China No. 1 Tian Xian Liquid)  Please see note below.    

Last June 1991, there were nights while I was sleeping that I would cough very hard, and throw up phlegm. Like normal procedure, I took common western & chinese herbal medicines to cure my simple disease.

But, this did not solve the problem. I then consulted a physician named Doctor Ang. He's an old doctor and thus, have a lot of experience. After taking an X-RAY (Figure 1), the doctor noted a slight enlargement near my left lung as compared to a normal X-RAY (Figure 2). "This is a very suspicious area, you'll have to go get a CT-SCAN.", the doctor suggested. I hesitated to have my CT-SCAN and just asked the doctor to prescribe some medicine. He prescribed some antibiotics, but unfortunately, it didn't work. I visited him again, and he gave me another similar set of antibiotics, only the name have been changed. But still, nothing worked. 

By November, I already have a fever.  After realizing that the medicine have no effect. I went to see another doctor, coincidentally, his name is Doctor Ang. The second doctor was older than the first and was very popular during the 1950's. After showing my previous X-RAY to the second doctor, he also gave me the same explanation and prescription. The medicine didn't work out again. The second time I went back to the doctor, he prescribed me a new set of antibiotics. This time around, the medicine didn't conform with my body and hence, I lost 8 pounds.

I took the medicine from November 11 to December 10, 1991. But, my fever worsen, my phlegm already contained blood, and my cough worsen. So, I went out to look for another doctor in a big hospital. This time around, the doctor (although named Doctor Ang again) was a young doctor. On December 10, 1991, the third doctor advised me to have another X-RAY and CT-SCAN. Two days later, I saw the result (Refer to Figure 3). The result was worse. The doctor didn't even believe that the man to whom the X-RAY belonged to was still alive.

X-RAY CONSULTATION REPORT :  Chinese General Hospital and Medical Center.  Case No. 360114.  Name : Sing Kio.   Referred by : Dr. R. Ngo.  Date : 12-10-91.  Clinical Data : CHEST.  Compared with the previous examination taken outside dated 11-11-91 shows interval progression of the atelectasis and infiltrates in the left lung base.   The right lung is clear.  Heart is not enlarged.  Diaphragm is intact.   IMPRESSION: Atelectasis and pneumonia infiltrates, left lung base showing interval progression.  Possibility of this being secondary to hilar compression cannot be ruled out.  

By : E. Dy M.D. (Radiologist)

The doctor said that the tumor is way too close to the heart. Hence, surgery, chemotheraphy, cobalt therapy is not possible even if the tumor was benign or malignant. To me, it was more of like a death sentence.

The CT-SCAN results (Refer to Figure 4 & 5) showed that the tumor was 9.4 cm X 6.4 cm. On that same day, the doctor didn't want to prescribe any medicine and advised me to consult a TEMT specialist to find out if there is something wrong with my throat. Result showed that there is an inflammation in my esophagus. The TEMT specialist recommended to perform a surgery within three days. I hesitated because I think there was nothing wrong with my throat (I had voice, I can eat, etc).

CT-SCAN details : Chinese General Hospital & Medical Center, Section of Computed Tomography. Name : Sing Kio. Age : 58. CT No. : 91-1870.  Referred by : Dr. R. Ngo. Date : 12-20-91.

Consultation Report : C.T. SCAN OF THE CHEST.  Contrast study of the chest shows a huge pulmonary mass in the left lower lobe measuring 9.4 X 6.4 cm.   This is attached to the hilum and pleura.  Nodular densities are seen in the hilum.  Acinar infiltrates are noted in the left upper lobe.  Fibrotic densities are seen in both apices.  The heart is lightly enlarged.  No lytic changes demonstrated. IMPRESSION:  Pulmonary mass, left lower lobe, malignancy is highly considered.  Attachment to the hilum and pleura is demonstrated.   Left hilar lymphadenopathy.  Fibrosis, both apices. 

By : Cesar S. Co. M.D.

After that, the doctor advised to me to go back after 2 days to withdraw and analyze some liquids from my backbone. I went back and the doctor withdrew some liquid from my backbone using a large needle. Result showed that I was cancer negative. The doctor thought that he didn't place the needle at the correct location, thus, he tried again with a second needle. Result also showed that I didn't have cancer. He immediately congratulated me because according to his findings, I didn't have cancer. To further confirm his findings, he suggested that a tube should be inserted through my nose to pull out some more liquids. I refused to do so. Still, the doctor doesn't want to prescribe any medicine because the disease was still unknown.

I went to look for another doctor. His name is Dr. Tan. He also said the same thing as what Doctor Ang claimed since they got the same education. He asked me to go to a Filipino hospital to withdraw some more liquids.

I went to the Filipino hospital. He inserted a tube to my mouth for five times and pulled out some more liquids from my lungs for analysis.

After three days, it was found out that I had malignant tumor. The doctor said that I can't be operated on, nor use chemotherapy nor cobalt therapy since it was near my heart. Thus, I don't have any other alternative except to take Chinese medicine.

X-RAY CONSULTATION REPORT :  Chinese General Hospital and Medical Center.  Case No. 360114.  Name : Sing Kio.   Referred by : Dr. R. Ngo.  Date : 2-15-92.  Clinical Data : CHEST.  Compared with the previous examination dated 12-10-91 shows marked interval decrease in the size of the atelectatic segment previously noted along the left paracardiacarea. The rest of the lungs remain clear except for some pulmonary scarring in the left apex. The heart is not enlarged. Costrophrenic angles are well-defined. 

By : T.U. Pastrana M.D. (Radiologist)

At that time, someone recommended the use of some basic Chinese medicine. Nothing changed in 20 days. Someone then recommended Tian Xian Liquid. After taking Tian Xian Liquid from January 10 to the end of February 1992 (approximately a month and a half), I had another X-RAY (Refer to Figure 6). The doctor said that the results was much better than the previous one (Refer to Figure 3), but still, this was a serious condition. My fever and cough improved, and vanished eventually.

Analysis of X-RAY:  Name : Sing Kio.   Age : 58.  X-Ray No. : 5619.  Date : 6-29-92. 

Examination : CHEST.  Examination of the chest shows the heart to be normal in size.  The aorta is slightly dilated.  Blunting of the left costophrenic sulcus is noted.  Apical pleural thickening is noted on the right.   Minimal fibrosis is noted in both upper lung fields, more on the right.  The finding appears to be inactive Koch's lesion.  Comparison with previous study will be of help.  Minimal fibrosis is also seen at the left base and could be due to residual change from previous pneumonia.

Summary : Examination of the chest shows minimal scar, both upper lung fields, appears to be inactive Koch's lesion.  Minimal fibrosis at the left base is also noted.

By : Lorna S. Yiu Yap, M.D.  Diplomate, American Board of Radiology and Nuclear Medicine.  645 Condesa Street, Binondo, Manila.

Along with Tian Xian Liquid, I also take fruit and vegetable juices (half slice carrots, apple, one third of a cucumber, long celery, 2-3 leaves of lettuce, sugar beet). After extracting the juices, I drank 3 glasses per day. I continued to take the Tian Xian Liquid until June (1992) before I had another X-RAY. My fever and cough got better. I took another X-RAY(Figure 7) showed that there was nothing wrong with me. I took the X-RAY on a commercial firm, not in the hospital. My tumor has vanished. The doctor said that it looked like a dry scar of tuberculosis. Then, I stopped taking the Tian Xian Liquid until now.

Sonographic/Radiographic Report :  ACCUVISION DIAGNOSTIC CENTER, INC.  Name : Sing Kio.  Date : 03/09/1998.   File No. : 980645.  Sonographic/Radiographic Report : Chest X-Ray :   Fibrohazed infiltrates noted in both upper lung fields.  Rest of the lungs are clear.  Hear and the rest of the chest findings are unremarkable.  Impression: MINIMAL : PTB. BOTH UPPER LOBES, ACTIVITY UNDETERMINED.

By : Ma. Teresa D. Fontillas. M.D.

Last month (March 1998), I took another X-RAY (Refer to Figure 8). The X-RAY further confirmed that there is nothing wrong with me.

Recently, I have been diagnosed with colon cancer. So, in April 1998, I started taking up the Tian Xian Liquid again. The doctor advised me to undergo operation for my colon cancer. I refused and wanted to rely only on the Tian Xian Liquid. I hope by next year, I could be here again and testify to the wonders of Tian Xian Liquid. My contact number is with Mr. Manuel Kiok. Should you be interested to get any help or any comment, please don't hesitate to contact me.

MY SECRET MEDICINE

Aside from the Tian Xian Liquid , I also used my very own secret medicine. This medicine can't be bought anywhere. You can't ask your friends to look for it. We need to depend on ourself in order to use this secret medicine. I know everybody is interested to know my secret medicine.  1. Strong determination, 2. Courageous spirit, 3. Optimistic, 4. Don't worry too much, 5. Don't be afraid

This secret that you've heard is very easy for some of you. But it is hard to apply it in the lives of the cancer patients. We know that in our environment, we have a lot of viruses. But thankfully, our body has antibodies which deals with these viruses. When we are healthy, our antibodies are strong, thus virus can't enter our body. But, when we have a lot of work, or we are over-tense, fatigue, stress-out, our antibody will get low, thus our body is vulnerable to viruses.

Thus, if a cancer patient is not tense and not nervous, he'll be able to maintain his antibodies. Afterwards, when we drink the medicine, the antibodies will be able to work together with the medicine. On the other hand, if a cancer patinet is tensed, scared or afraid, he'll be weak and the medicine won't have any effect on him. This is the primary reason on why some of the cancer patients doesn't get cured by the Tian Xian Liquid.

Comment by the International Distribution Manager to Mr. Sing Kio's testimony :

* I want to comment on the testimony of Mr. Sing Kio. There are some things I would like to bring to everyone's attention. This medicine (Tian Xian Liquid) is most effective when used together with western medicine. Mr. Sing Kio said that he didn't use any western practice (i.e. surgery, chemo), is 'lucky'. It is not safe to say that we should only depend on the Tian Xian Liquid. With western treatment and the full support of Tian Xian Liquid, the result will be at its best.

Lung Cancer Disappeared in 5 Months

Mr. Heng Chew Hong (63, Malaysia)

In March 1997, my doctor urged me to have my annual checkup.  He said that it is a good habit for elderly people to maintain a regular annual medical check up.

It was during this check up that a 3 X 2 cm 'shadow' was found in my left lung. The doctor suspected that it was a tumor and a biopsy is necessary to find out whether it was benign or malignant.  The result of the biopsy would also determine if a surgery is necessary.

I was worried that I'm not strong enough to undergo surgery. Hence, I started to look for a medicine treatment in order to prevent surgery.

In May 1997, I heard that Mr. Wang Zhen-Guo (a famous anti-cancer herbalist) would come to Malaysia to provide free consultation for cancer patients.

I was able to consult Mr. Wang with my condition and he prescribed Tian Xian Liquid, Tian Xian Capsule #5 and Tian Xian Plaster.  He recommended the treatment for at least one course.

The X-ray exam on June 23, 1997, indicated that the size of the tumor was reduced by half to 1.5cm. I was shocked by the result as I did not expect this miracle.

I was very satisfied. During the course of the treatment, I felt that I was more energetic and developed a good appetite. I followed Mr. Wang's prescription and continued with Tian Xian Liquid. I hope that the tumor in my lung will one day disappear totally.

The X-ray as of October 25, 1997, showed that the tumor has totally diminished. My dream was fulfilled.  I am very happy that Mr. Wang offered me a SUFFERING-FREE anti-cancer treatment.

Even though the tumor was gone, I still continue with Tian Xian Liquid at a smaller dosage to prevent any relapse.

The X-ray on March 2, 1998, confirmed that the cancer is not there anymore!

Is Tian Xian Liquid really effective ?

                Yes, it is effective. Based on different conditions of each patient and the stages of cancer, Tian Xian Liquid will have different level of effectiveness. It is effective when the expected effectiveness is achieved for a specific stage of cancer.

What does "expected effectiveness for a specific stage of cancer" mean?

                (1) Last stage cancer: Tian Xian Liquid can release pain and prolong life span. Most last stage cancer patients would rest peacefully.

(2) Middle stage cancer: When combined with western medical treatment, Tian Xian Liquid can help patients improve day by day. Patients are required to take the medicines at the dosage and time suggested in order to achieve the expected effectiveness (control the growth of cancer, prevent metastasis and further reduce of size of tumor).

(3) Early stage cancer: When combined with western medical treatment, Tian Xian Liquid can destroy cancer cells and control cancer relapse effectively. In addition, it can ease the side effects resulted from chemotherapy or radiotherapy.

In order to achieve expected effectiveness for a specific stage of cancer, patients must have faith and courage to fight against cancer in the long term.

What does 80.2% effective rate mean?

                It represented an aggregate of 80.2% among the clinical cases when standard dosage was applied.

1.2% Relief Rate: over 50% reduction in size of tumor focus which sustained for over 4 weeks.

2% Improvement Rate: tumor focus diminished by 25% but under 50% which sustained for at least 4 weeks.

77% Stabilization Rate: tumor focus diminished by or under 25% with no growth or new focus.

Is Tian Xian Liquid guaranteed to be absolutely effective?

                Unfortunately not. It is the most effective Chinese medicine especially when combined with western medical cancer treatment. Based on past experience, Tian Xian Liquid is able to strengthen the immune system and prolong patient's life span. A well kept physical condition allows patients a chance to wait for a more advanced and effective medicine and treatment for cancer in the future.

In addition to Tian Xian Capsule #3, what other method can lessen the side effects, such as nausea, vomiting, etc., resulted from chemotherapy or radiotherapy?

                Pasting Tian Xian Plaster on the uncomfortable areas will lessen these side effects.

 What is the standard dosage?

                A standard dosage is suitable for early and middle stage cancer patients, and those at recovery phase. A standard dosage requires patients to take Tian Xian Liquid 40cc a day (4 times a day), 10cc each time at 9AM, 3PM, 9PM, and 3AM. If it is inconvenient for the patient to wake up at 3AM, patients may take 20cc at 9AM or 9PM.

What is an increased dosage?

                An increased dosage is suitable for terminal stage cancer patients and those undertaking special treatment. An increased dosage requires patients to take 60cc a day (6 times a day) 10cc each time at 6AM, 9AM, 12PM, 3PM, 6PM, and 9PM. If patients are taking other medicines and health supplement, they can take 20cc each time at 9AM, 3PM and 9PM.

What is the difference between standard and increased dosage?

                During the past few years, most of our patients were at the last or terminal stages of cancer. Some of them could not receive western medical treatments due to various reasons. As a result, standard dosage was not effective enough for most patients. An increased dosage is strongly recommended.

Why is it recommended to take Tian Xian Liquid at 9AM and 9PM?

                Research indicates that cancer cells are most active and replicate fastest at 10 to 11 o'clock both in the morning and at night. If patients can take Tian Xian Liquid at 9AM and 9PM, the medication will be more efficient in controlling the growth of cancer cells during this period.

Is there a maximum dosage for Tian Xian Liquid?

                The maximum dosage for Tian Xian Liquid is 120cc a day. Taking too much of any medicine will burden the liver and kidney.

What is maximum number of Tian Xian Suppository to be applied each day ?

                The ingredients of Tian Xian Suppository consists of strong  anti-cancer medicines. The maximum number to be used daily is 4 granules.

Should Natural Nutritious Liquid be taken constantly?

                The fact is that physical condition will become less healthy as people get old. In addition, the external environment is becoming more harmful to our body. As a result, we need health supplements to maintain physical functions. It would be beneficial to take Natural Nutritious Liquid constantly.

Constipation may occur after taking Tian Xian Liquid. What should be done?

                Since it contains animal bile (according to Chinese medicine, it is a cool medicine) if the patient has hot physique, there is a slight chance of having constipation. This may be relieved simply by taking some saline water before breakfast in the morning. Patients are advised to include high fiber products in their daily diet.

Diarrhea may occur after taking Tian Xian Liquid. What should be done ?

                This usually happens to patients with cool and vague physique. This may be relieved by drinking red dates (5 to 7 pieces) and ginger (3 to 5 slices) water for 3 to 5 days.

Epigastric pain may occur after taking Tian Xian Liquid. What should be done?

                This is due to Tian Xian Liquid's function of activating blood circulation and removing bruise. This symptom often happens to patients whose malignancy is in the area of lungs. This symptom would disappear after one course of the dosage.

Continuous belching may occur and the stomach may feel hot after taking Tian Xian Liquid. What should be done?

                This usually happens to the patients who have chronic gastritis and peptic ulcer when they started the application of Tian Xian Liquid. Improvement may be obtained by drinking red dates and ginger water. Gastritis may also be cured after one course of dosage.

Gasp may occur and the heart-beat may become faster after taking Tian Xian Liquid. What should be done?

                Tian Xian Liquid has the effect of accelerating blood circulation and relief of the symptom may be obtained continuation of dosage. This usually happens to a small minority of people with weak heart function. You may simply reduce the amount and increase the number of dosage. Heart stimulant is not required.

Dizziness may occur after taking Tian Xian Liquid. What should be done?

                This is mainly due to excessively weak physique of patients. It will be relieved after one week by simply reducing the dosage till patients get used to the medicines. Remember to increase the dosage when the symptom is gone.

Poor appetite and nausea may occur after taking Tian Xian Liquid. What should be done?

                Taking Tian Xian Liquid will not cause poor appetite and nausea. If undertaking chemotherapy or radiotherapy, patients will experience vomiting, nausea, and etc. They may resist the smell of the herbal medicine. You may reduce the amount of Tian Xian Liquid and increase the use of Tian Xian Suppository till these symptoms lessen.

Blood pressure may rise after taking Tian Xian Liquid. What should be done?

                Tian Xian Liquid has the function of accelerating blood circulation. This is a temporary symptom and will not cause cardio vascular disease. If you are suffering from hypertension, please continue taking the tension-relief medicine.

If patients suffering diabetes experience increased blood sugar, what should be done?

                Tian Xian Liquid should be taken in conjunction with blood-sugar-reduction medicines. Patients should visit their doctors on the regular basis to follow up with the reading of blood sugar level.

Patient's skin tone may become darker after taking Tian Xian Liquid. What should be done?

                This usually happens to liver cancer patients. After 2 to 3 months period of dosage, normal state will resume.

Haemorrhoids may occur after taking Tian Xian Liquid. What should be done?

                This is a sign of expulsion of toxic substances out of the body for patients who originally suffer from Haemorrhoids. It is better to ask a surgical doctor to sterilize and bandage to avoid contamination of germs. Tian Xian Suppository can be applied to help cure haemorrhoids after the wound had healed.

What are the body reactions showing that Tian Xian Liquid has become active in the body?

                After 3 to 5 days of application, some body reactions such as pain, sore , and fatigue will occur based on the focus and the extent of the diseases. These are improvement body reactions which will go away when patients get used to the medicines after continuous application.

Vomiting and bloody stool may occur to a gastric cancer patient after the dosage. What should be done ?

                Vomiting: The dosage may be taken along with fresh ginger slices and red dates prepared in boiling water.

Bloody stool: If bloody stool occurs, please ask a doctor to examine whether it is the metastasis of the cancerous cells to the large intestine or rectum.

Aching may occur throughout the body after taking Tian Xian Liquid. What should be done?

                This is the normal sign of having smooth circulation of the blood networks and a sign of medicinal herbs in fighting against cancer cells. The dosage should be continued and relief will result in 1 or 2 weeks.

How to take Tian Xian Liquid when oral ulcer occurs after chemotherapy?

                Dilute Tian Xian Liquid with the same amount of water and take the diluted medicines slowly. Tian Xian Suppository is strongly recommended to enhance the effect of Tian Xian Liquid and to stop pain.

How to take Tian Xian Liquid when patients need the assistance of gavage?

                Inject Tian Xian Liquid first and 15cc of water using syringe into gavage to make sure Tian Xian Liquid flow into stomach.

How should patients suffering from ascites utilize Tian Xian Liquid and its serial products?

                For serious ascites, western medical treatment is required to expel the water. Application of Tian Xian Liquid, Capsules, and Suppository will be able control ascite from developing too fast at the early stage.

What should be done when cancer patients catch a cold?

                When patients or family members have symptoms of flu, please add 20cc of Tian Xian Liquid to the suggested dosage for at least 7 days to strength immunity functions to fight against virus.

Why is the taste of Tian Xian Liquid sometimes differ?

                It is because of the difference in concentration and sweetness of the honey produced by the bees from different flowers over the seasons. You may therefore feel some difference in the prescribed Tian Xian Liquid.

May Tian Xian Liquid be taken before and after a surgical operation or before, during and after chemotherapy ?

                If your doctor requires fasting, you should not take Tian Xian Liquid until you finish the therapy. If the doctor did not require fasting, you may continue the dosage. You can resume the dose after the surgery -- with doctor's permission to take some liquid diet.

Which Tian Xian Capsule is most suitable for patients with few new focuses of cancer metastasis?

                Patients with few new focuses of cancer metastasis may choose Tian Xian Capsule based on either the latest focus of metastasis or the most uncomfortable part. If patients undertook many courses of chemotherapy or radiotherapy which may cause hemopoiesis function disturbance, long-term application of Tian Xian Capsule #3 is strongly recommended to strengthen weak physique.

If patients have difficulty to swallow the Tian Xian Capsule, what shall be done ?

                                                                                                      

Just open the capsule and mix with the medicated powder with honey water. The curing effect is even better than swallowing the capsule.

How do rectal cancer patients who was implanted with tracheotomy (artificial anus) use Tian Xian Suppository?

 If the wound has not yet healed, do not use the suppository. If wound has been healed for at least one month and the patients does not experience slight diarrhea, insert suppository directly into tracheotomy.

Can Tian Xian Suppository be used for all kinds of cancer?

 Yes. The medication of Tian Xian Suppository is absorbed directly through local mucosa and blood vessel. When combined with Tian Xian Liquid and Capsule, it can effectively control cancer growth, prevent metastasis and relieve pain.

What kinds of cancers require application of Tina Xian Plaster ?

                Tian Xian Plaster can be used externally for those cancer diseases close to body surface. Tian Xian Plaster can resolve masses and relieve pains, stop bruise and remove swells. Combined with Tian Xian Liquid and Capsule, the curing effect can be increased by absorption of the medicine through different networks.

What should be done if the patient is too weak ?

                For those patients who receive frequent chemotherapy and radiotherapy and are at last stage of cancer, in addition to the application of Tian Xian Liquid, Capsule, Suppository and Plaster, Natural Nutritious Liquid may be taken both in the morning and at night to strengthen the body.

A patient of nasopharyngeal carcinoma who receives repeated radiotherapy will experience difficulty of opening his or her mouth. What should be done?

                This will be improved by pasting Tian Xian Plaster on the cheeks once a day for eight hours.

Can patients undergoing hemodialysis take Tian Xian Products?

                Patients are not recommended to take Tian Xian Products on the day of hemodialysis. Patients can resume application after hemodialysis.

Is it helpful to take Tian Xian Liquid for benign tumor?

                Yes. Taking it at the standard dosage for 3 to 6 months will reduce the tumor size significantly. It may be taken to prevent it from developing into malignant tumor.

When rashes, pimples or uloncus occur after taking Natural Nutritious Liquid, what should be done?

                These are improvement reactions. If these symptoms become worse, please stop the dosage until these symptoms disappear which usually takes 7 to 10 days. You may resume with smaller amount of the dosage and gradually increase to 20cc a day.

Are there any counterfeits for Tian Xian Liquid?

                All high quality products may be imitated all over the world. Many customers bought counterfeits because they did not know how to differentiate counterfeits. Our company have invested on the research and development on the new package for Tian Xian Liquid which will be available starting on December 1998. Please recognize clearly the new look of Tian Xian Liquid and consult with genuine contracted distributors.

Can patients take other Chinese medicines or supplements when they take Tian Xian Liquid?

                It is very important to take Tian Xian Liquid at the suggested time. Patients can take calcium, iron, hormone and other Chinese medicines that are supportive to the blood and vital energy at the interval of one hour. Other anti-cancer herbal medicines are not recommended because some of the ingredients might be overlapping or contradicting. Patients do not have to add ginseng in the treatment because the ginseng used in Tian Xian Liquid was from Changbai Mountain which is proved to be the most effective ginseng compared to ginsen from other areas. Patients also need to select other supplements wisely.

Is it necessary to take Tian Xian Liquid for one's whole life ?

                As long as the cancer has been stabilized, the dosage can be adjusted and reduced. It is strongly recommended that patients conduct follow-up examination on the regular basis. Generally, the dose applications are divided into 3 stages:

a. In the case of combined application with surgery and chemotherapy, we recommend the dosage be followed for 3 to 6 months until examination confirms that the tumor have diminished or disappeared.

b. During the next two years, please change to one month dosage per quarter. That is, by having the dose for one month while on suspension for the next two months.

c. Owing to the high relapse rate of as much as 60% within 5 years of the cancer disease, dosage should be taken for one month in March and September during the three subsequent years.

If taking Tian Xian Liquid continuously, patients will prevent other diseases due to well regulated constitution and strengthened immune system.

Which cancer disease is Tian Xian Liquid most effective on ?

                When destroying cancer cells, Tian Xian Liquid is able to strengthen the immunity functions of the body at the same time. The therapeutic theory focuses on the total rebuild of body to restore health and eliminate illness. Therefore it is very effective to numerous types of cancer disease. Since it is by oral application, it has the greatest effect to cancers of the digestive system.

When should Tian Xian Antitussivese Capsule be used?

                It is used for lung cancer patients who have acute and chronic tracheitis, hypersensitive asthma, chest distress, and cough. Combined application of Tian Xian Antitussives and Tian Xian Plaster can ease these symptoms effectively.

When should Tian Xian Ostitis Tablet be used?

                It is applied for patients who have bone cancer, osteometastasis and osteoporosis. Combined application of Tian Xian Ostitis Tablet and Tian Xian Plaster can effectively help release pain.

Are the white spots on the surface of Tian Xian Suppository traces of mildew?

                The white spots are one of the constituent medical substances, which may also prevent the Tian Xian Suppository sticking onto the package bag.

How to use Tian Xian Suppository properly?

                Tian Xian Suppository is to be inserted into anus or vagina and is dissolved by body temperature. You may apply lubricant such as Vaseline on the surface of the Tian Xian Suppository for a smoother insert. Please insert suppository 3 to 5 cm deep and rest on the bed for 20 minutes so that suppository will not fall out of the body.

What should be done if the affected part is sensitive and itching after application of Tian Xian Plaster?

                This indicates that you have sensitive skin. Please apply a thin film of galactic liquid or lipa before pasting the Tian Xian Plaster. Depending on the reaction of the skin, remove it within 4 hours or if adverse sensation occurs.

Are there any laboratory tests conducted on Tian Xian Liquid?

                A: Yes. Many animal experiments and clinical trials have been conducted during the research and development of Tian Xian Liquid. Recently, Free Radical Biology & Development Center in Taipei, carried out four experiments which were directed by different research institutes.

What are the experiments conducted by Free Radical Biology & Development Center in Taipei?

                Experiments on removal of free radical by Institute of Biophysics, Academia Sinica, Beijing Bradford Research Institute, CA, USA.

                Toxicology experiments by Institute of Biophysics, Academia Sinica, Beijing Bradford Research Institute, CA, USA.

                Immunization function tests by Institute of Biophysics, Academia Sinica, Beijing Bradford Research Institute, CA, USA.

                Inhibition effect on tumor by Guangzhou Tumor Institute.

What are the results of the experiment on removal of free radical?

                Tian Xian Liquid is able to effectively remove:

                Superoxide free radical with clearance capacity of 300,000 unit of SOD activity per c.c.

                free radical generated by white blood cells which vitamin E fails to effectuate.

                hydroxyl free radical which vitamin C fails to effectuate.

                capacity to remove lipide peroxide is much higher than that of vitamin E.

What are the results of the experiment on toxicology?

                Based on experiments conducted on mice, Tian Xian Liquid was able to pass stringent acute toxicity test, micro-nuclear of bone marrow cell test, sperm distortion test and Ames test respectively.

What are the results of the experiment on immunization function tests?

                Animal experiments on mice showed that Tian Xian Liquid may increase the phagocytosis of macrophage, strengthen lymphatic conversion for the spleen and raise the serum hemolysis reaction and anti-host reaction which indicated significant benefits to immunization.

What are the results of the experiment on inhibition effect on tumor?

                As evidenced in the test on mice in sarcoma and hepatocele, inhibition effect shown as not inferior to chemical (5-Fu). Quantum effect reaction was observed which indicated that the larger the dosage, the better the inhibition effect. This was greatly superior to a reference group of glossy ganoderma and green algaes etc..

It is said that many herbal medicines produced in China have high heavy metal contents. What are the heavy metal contents in Tian Xian Liquid?

                Micro elements are essential for anti-cancer effect. However, the heavy metal contents beyond the tolerance of human body will burden the liver and kidney. Every batch of Tian Xian Liquid is submitted to SIGs of Hong Kong for test of heavy metal contents, including cadmium, chromium, mercury, arsenic, lead, aluminum, antimony and tin. The test result shows that the contents are far below the standard prescribed by the Hong Kong Government and world class standard (Test report available upon request).

What kinds of food should patients consume more?

                Patients are advised to eat more mushroom, garlic, vinegar and bean products.  Patients are advised to eat less dark meats and more white meats. Dark meats are categorized as acid food. Acidified constitution has higher possibility to lead to cancer in the future. Milk and eggs with rich protein can provide energy and nutrition. Due to slower gastroenteric wriggle, patients need more high fiber diet such as oatmeal, fruit and vegetables to avoid constipation and flatulence. Bean products and milk easily produce gas in the stomach. As a result, patients should consume small amount of bean products, soy bean milk and milk each time. Variety of foods is recommended.

What kinds of food should patients avoid?

 Patients should not eat crab, chicken skin, chili and alcoholic.

Why is it more effective when Tian Xian Liquid is combined with western medicine?

 Western cancer treatment has been the most effective and direct method for curing cancer. However, western treatment faces bottleneck in body reconstruction. The concept of Chinese medicines emphasizes on the improvement of immune system and regulating constitution which enables body cell to be repaired and basic functions to be restored.

This will complement what western treatment fails to accomplish. According to the past experience, taking Tian Xian Liquid for a certain period of time before the surgery can possibly reduce the size of tumor which will make surgery easier to remove the reduced tumor. Taking Tian Xian Liquid after the surgery will shorten patient's recovery period and prevent metastasis and relapse.

Taking Tian Xian Liquid will significantly ease the side effects, such as vomiting, nausea, oral ulcer, decrease in white cell count, associated with chemotherapy or radiotherapy which often administered before the surgery. It also will enhance the effectiveness of chemotherapy and radiotherapy.

Can patients take Tian Xian Liquid only for cancer treatment and not receive chemotherapy, radiotherapy and surgery?

 We strongly recommend to our patients not to give up on western treatment. Even though most patients who considered Tian Xian Liquid could not receive surgery or had fear of the side effects associated with chemotherapy or radiotherapy, we try to educate our patients that western medical treatment should be the focal point to cure cancer with the complement of Tian Xian Products. Based on the past experience, the effectiveness was enhanced for last stage cancer patients when the combination of western treatment and increased dosage of Tian Xian Liquid and its serial products was performed. Some patients, who could not receive western treatment, applied Tian Xian Liquid at increased dosage with the supplement of serial product properly and earned a chance to be able to receive western treatment.

During fever, may Tian Xian Suppository be applied as antipyretic?

 Tian Xian Suppository has heat relief effect. For against fever caused by infection of virus, it is not advisable to use Tian Xian Suppository for abatement of fever.

Can Tian Xian Suppository be used to cure feminine diseases?

 Yes. Due to its antiphlogistic, styptic and anti-itching effects, it may be used to cure vaginitis, vaginitis trichomonas, venereal disease and cervical cancer.

Can Tian Xian Suppository cure hemorrhoids?

 Yes. Tian Xian Suppository may relieve the pains of hemorrhoids. If hermorrhoids already break out and bleed, western treatment is required to stop bleeding. If it is only swollen, continuous use of Tian Xian Suppository can heal hermorrhoids in a short period of time. What is most important is to have regular life style and eat more fruit and vegetables.

During headache, can pain be relieved by pasting of Tian Xian Plaster ?

 Yes. Paste it on the temples and between eyebrows for 30 minutes and the pain will generally lessen.

During sore waist and backache, can pain be relieved by pasting of Tian Xian Plaster ?

 Pains may be relieved by pasting Tian Xian Plaster on the wider area where pains occur. It is very important to visit your doctor to find out the reasons that cause pains.

Is it helpful to have Tian Xian Plaster pasted for coughing and sore throat?

 Swelling may be removed and pain relieved. Recovery will be achieved in 3 to 5 days when used with Tian Xian Antitussives Capsules.

During toothache, can pain be relieved by pasting of Tian Xian Plaster ?

 Yes. By pasting on the affected part, pain will generally be relieved in 20 minutes. Please visit your dentist for a proper exam.

Can Tian Xian Plaster cure cracking hands and beriberi?

It has specific effect to cure cracking hands and beriberi which requires time and patience. It is advised to combine with western treatment.

On dysmenorrhea, can pain be relieved by pasting of Tian Xian Plaster ?

 Pasting it on the abdomen will result in obvious pain relief. To have better effect, apply it on the abdomen with a hot compress.

What should be done when there is chest distress and the pectoralgia occur?

 Please have your doctor find out the causes of chest distress and pectoralgia.

Can abdominal pain be relieved by pasting Tian Xian Plaster ?

 Pain can be relieved. Diagnosis should be conducted to find out the cause of the pain to prevent a misjudge.

Is it useful to have Tian Xian Plaster pasted to relieve muscle pain caused by exercises?

 It has the effect of detumescence and may prevent other diseases caused by stasis of blood and injury of the tissues. If you do not know the cause of the pain, please ask your doctor for a exam.

Is it helpful to use Tian Xian Plaster for nasal obstruction?

 Yes, pasting on the temples and between eyebrows for antiseptic and soothing effects. It is important to have examination and treatment in the hospital.

For scapulohumeral periarthritis, is it helpful to paste Tian Xian Plaster to relieve pain ?

 It may be pasted on the affected part for a week to relieve or cure the pain.

Is it helpful to use Tian Xian Plaster for stiff neck?

 Yes, applying on the lower backneck. Please refer to the Tian Xian Plaster application demonstration.

Is it helpful to paste Tian Xian Plaster for spur?

 Yes. This should cope with adjustment to the vertebra.

Can pain be relieved for rheumatalgia and arthritis by Tian Xian Plaster ?

 Yes. It has the effects of expelling the wind, relaxing muscles, and relieving pain. Please remember to take care of daily life and keep warm. The effects can be enhanced by applying Natural Nutritious Liquid.

Is it effective for viral hepatitis A, B and C sufferers to take the Tian Xian Liquid?

Yes. By taking Tian Xian Liquid in conjunction with Tian Xian Capsule No. 6 , the liver functions may be strengthened to prevent cirrhosis.

After the index has dropped after taking Tian Xian Liquid, may a viral hepatitis A, B and C sufferer stop the dosage?

 When the index has dropped to the normal rating, the dose should be maintained but may be reduced.

Is it effective to take Tian Xian Liquid for cirrhosis?

By taking Tian Xian Liquid in conjunction with Tian Xian Capsule No. 6, the liver functions may be strengthened to prevent against liver cancer. When improvement occurs, please take Natural Nutritious Liquid to maintain the condition of liver.

Does Natural Nutritious Liquid have any effect on sensitive skin?

 Generally, Natural Nutritious Liquid will strengthen immune system and improve physical nature. Improvement of sensitive skin problem will be achieved through long term application.

Can Natural Nutritious Liquid improve irritability, insomnia and dreaminess?

 Yes, these symptoms will be improved in few days. To maintain the improvement, please continue the application for at least 3 months.

Can Natural Nutritious Liquid regulate menstruation irregularity and disorder of internal secretion and even have beautifying effect?

 Taking Natural Nutritious Liquid can stimulate metabolism, regulate endocrine imbalance and beautify skin. Better results can be achieved by continuous long term application.

Can teenage girls take Natural Nutritious Liquid?

 

Yes. Natural Nutritious Liquid can smooth the circulation of blood networks. Therefore, it can improve irregular menstruation and menoxenia.

Is Natural Nutritious Liquid effective in improving hyperthyroidism or hypothyroidism?

 

It is suggested to combine western and Chinese herbal treatment. The western curing effect will be enhanced by taking Natural Nutritious Liquid.

Is Natural Nutritious Liquid effective for dim-sighted, acerbity or sensitivity caused by prolong improper use of the eyes?

 

Yes, Natural Nutritious Liquid may be applied to help recover from eye fatigue. It is important to take good care of eyes.

Is it effective to take Natural Nutritious Liquid for soreness of waist, backache, shoulder aching pain and lumbago due to the kidney deficiency of the aged ?

 

It is effective. These will be improved by merely taking Natural Nutritious Liquid and Tian Xian Plaster.

For those having weak stomach due to poor digestive system and absorption function, is it effective to take Natural Nutritious Liquid ?

 

Yes, Natural Nutritious Liquid can protect stomach mucosa and therefore is very effective for peptic ulcer. It requires long term application and regular eating habits.

Is Natural Nutritious Liquid effective for Gout?

 

Yes, because it can smoother the circulation of blood networks, remove swell and bruises. It can effectively ease the pain from Gout. Western medicines are necessary in the beginning of the treatment. When the symptoms diminish, western medicines can slowly be decreased.

Is Natural Nutritious Liquid suitable for those people who have very weak constitution and have been ill for a long period of time?

 

Yes. Taking Natural Nutritious Liquid can improve immunity function and energy during restorative period for both children and adults who are very weak, catch a cold easily, and have been through surgery. It is a very simple, safe, convenient and effective health supplement.

Is Natural Nutritious Liquid suitable for those people who suffers from brain nerve weakness?

 

Yes. Taking Natural Nutritious Liquid can increase the oxygen utilization in the brain which will improve migraine, incapability to focus and impaired memory resulted from excessive use of brain and brain nerve weakness.

Can Natural Nutritious Liquid improve symptoms associated with menopause?

 

Yes. The ingredients of Natural Nutritious Liquid can improve constitution and maintain the level of red blood cell count. The symptoms can be lessen.

Can Natural Nutritious Liquid promote liver functions and neutralize drinking effects?

 

Yes. It can prevent infection of hepatitis and increase the detoxifying function of liver. Taking Natural Nutritious Liquid before and after drinking alcohol has an inhibitory effect on ethanol which causes drunkenness and promotes the metabolism of alcohol.

 

NOTE:

1.        During treatment period, dont eat things such as crabs, chicken skin, chili and alcoholic drink.

2.        It is beneficial to the treatment to eat things such as garlic, mushroom, vinegar and bean products.

3.        For all kinds of TIAN XIAN CAPSULE (WAN), if anyone after taking those pills has a stomach upset, please stop taking for several days, then continue to take them.

4.        Pregnant women are not allowed to take above medicines.

Cancer-herbs.com covers the China No. 1 Tian Xian range of serial products. The Tian Xian products are herbal nutritional supplements. The natural herbal ingredients aims to strengthen the body's immune system. Our body's internal defense will attack and destroy tumor and cancer cells. It's the body's natural defenses working. It complements the western therapies.

Though currently produced in China, expansion plans are in progress. It will be produce simultaneously in the United States, specifically for the American market, before the end of the year 2000.

Testimonials of cancer survivors are from USA, Japan, Hong Kong, India, China, Philippines, Taiwan, Thailand, and Malaysia. The list of testimonials are added regularly.

Two books have already been published. Detailing how Tian Xian was discovered, it's function and numerous cancer survivors stories. The publications, beside English, are available in Chinese, Japanese, and Korean.

Some of the major awards and recognitions that were received by Professor Wang Zhen Guo:

China President Jiang Zemin (Middle) congratulates Prof. Wang Zhen Guo (Left) -- inventor of Tian Xian products.

 Prof. Wang Zhen Guo (left) receives the Best Invention Award by Individual Research in the World at the 38th World Eureka Invention Expo in Brussels, Germany (Cancer-Herbs.com)

Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer

This study is currently recruiting patients.

Sponsored by

Southwest Oncology Group

National Cancer Institute (NCI)

 Purpose

RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill cancer cells.

PURPOSE: Phase I trial to compare two different vaccines in treating patients who have gastric cancer, non-small cell lung cancer, prostate, or ovarian cancer.

Condition  Treatment or Intervention Phase

adult brain tumor

Gastric Cancer

Non-small cell lung cancer

ovarian epithelial cancer

Prostate Cancer

  Drug: EGFR antisense DNA

 Drug: keyhole limpet hemocyanin

 Drug: sargramostim

 Procedure: antisense therapy

 Procedure: biological response modifier therapy

 Procedure: non-specific immune-modulator therapy

 Procedure: non-tumor cell derivative vaccine

 Procedure: vaccine therapy

 Phase I

 MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Lung Cancer;   Ovarian Cancer;   Prostate Cancer;   Respiratory Diseases;   Stomach Cancer

Study Type: Interventional

Study Design: Treatment

Official Title: Phase I Study of EGFRvIII Peptide Vaccine With Sargramostim (GM-CSF) Versus Keyhole Limpet Hemocyanin as Adjuvant in Patients With EGFRvIII-Expressing Cancer

Further Study Details:

OBJECTIVES:

Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.

Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.

Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.

OUTLINE: Patients are assigned to one of two treatment arms.

Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.

Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly. Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of one the following:

Stage II-III gastric cancer

Stage II-IIIA non-small cell lung cancer

Stage IIC-IV ovarian cancer in first complete remission

CA 125 normal and stable*

Grade III anaplastic astrocytoma

Stage IV (M1) prostate adenocarcinoma

No small cell variations

Must be receiving androgen blockade

Prostate-specific antigen less than 5 ng/mL and stable*

Documented EGFRvIII expression in primary tumor

Must have received prior surgery and or chemoradiotherapy for disease (except prostate cancer patients) NOTE: *Stable defined as no increase over 2 measurements at least 28 days apart with the last measurement within the past 28 days

PATIENT CHARACTERISTICS: Age:

Not specified

Performance status:

Zubrod 0

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3

Platelet count at least 100,000/mm^3

Hemoglobin at least 10 g/dL

Hepatic:

SGOT no greater than 2.5 times upper limit of normal (ULN)

Alkaline phosphatase no greater than 2.5 times ULN

No hepatitis

Renal:

Not specified

Other:

No other malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

No contraindication to receiving sargramostim (GM-CSF) or KLH-based vaccine products

No autoimmune disease

HIV negative

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

At least 1 month since prior cytotoxic chemotherapy

No concurrent chemotherapy

Endocrine therapy:

See Disease Characteristics

At least 1 month since prior treatment dose corticosteroids

No concurrent corticosteroids

Radiotherapy:

See Disease Characteristics

No concurrent radiotherapy

Surgery:

See Disease Characteristics

Other:

Recovered from all prior therapies

No concurrent enrollment on other phase I studies

No other concurrent immune modulators

EP-2101 Vaccine in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer

This study is currently recruiting patients.

Sponsored by

Epimmune

Purpose

RATIONALE: Vaccines such as EP-2101 made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of the EP-2101 vaccine in treating patients who have received standard therapy for stage IIB or stage IIIA non-small cell lung cancer.

Condition  Treatment or Intervention Phase

stage II non-small cell lung cancer

stage IIIA non-small cell lung cancer

  Drug: EP-2101

 Drug: Montanide ISA-51

 Procedure: adjuvant therapy

 Procedure: biological response modifier therapy

 Procedure: non-specific immune-modulator therapy

 Procedure: non-tumor cell derivative vaccine

 Procedure: vaccine therapy

 Phase I

 MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer;   Respiratory Diseases

Study Type: Interventional

Study Design: Treatment

Official Title: Phase I Study of Adjuvant EP-2101 Peptide Vaccine in Patients With Stage IIB or IIIA Non-Small Cell Lung Cancer

Further Study Details:

OBJECTIVES:

Determine the safety and tolerability of EP-2101 peptide vaccine in patients with stage IIB or IIIA non-small cell lung cancer.

Determine the frequency of response in patients treated with this vaccine.

Determine the breadth of tumor-associated antigen-specific cytotoxic T-lymphocyte (CTL) response in patients treated with this vaccine.

Determine the magnitude of each epitope-specific CTL response in patients treated with this vaccine.

Determine the overall CTL response for each epitope in patients treated with this vaccine.

OUTLINE: This is an open-label, multicenter study.

Patients receive EP-2101 peptide vaccine emulsified in Montanide ISA-51 subcutaneously every 3 weeks for a total of 6 vaccinations in the absence of unacceptable toxicity.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer meeting 1 of the following staging criteria:

Stage IIB (T2, N1, M0 or T3, N0, M0)

Stage IIIA (T1, N2, M0; T2, N2, M0; T3, N1, M0; or T3, N2, M0)

No evidence of disease after prior standard treatment with curative intent

Therapy completed within the past 4 to 12 weeks

HLA-A2 positive

PATIENT CHARACTERISTICS: Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin at least 10 g/dL

Platelet count greater than 100,000/mm^3

WBC greater than 3,000/mm^3

Absolute neutrophil count greater than 1,500/mm^3

Absolute lymphocyte count greater than 500/mm^3

Hepatic

AST and ALT no greater than 2.5 times upper limit of normal (ULN)

Bilirubin less than 3 mg/dL

Alkaline phosphatase no greater than 2.5 times ULN

No history of hepatitis B or C

Renal

Creatinine no greater than 1.5 times ULN

Immunologic

No prior serious adverse reactions, including anaphylaxis and related symptoms such as hives or respiratory difficulty, to any vaccines

No prior hypersensitivity to any components of the study vaccine

No history of any of the following conditions:

Systemic lupus erythematosus

Scleroderma

Connective tissue disease

Sjögren's syndrome

Rheumatoid arthritis

Inflammatory bowel disease

HIV negative

Other

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception during and for 3 weeks after study treatment

No other prior cancer except successfully excised nonmelanomatous skin cancer or surgically cured carcinoma in situ of the cervix

No other acute medical condition that would preclude study therapy

No mental or psychiatric condition that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

No prior vaccine therapy for cancer

More than 1 month since prior interferon therapy

More than 1 month since prior interleukin therapy

More than 1 month since prior influenza vaccine

More than 1 month since other prior immunomodulatory agents

No other concurrent immunomodulatory agents

No concurrent influenza vaccine

Chemotherapy

Not specified

Endocrine therapy

More than 1 month since prior systemic corticosteroids

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent participation in any other investigational study

Vaccine Treatment for Advanced Non-Small Cell Lung Cancer

This study is currently recruiting patients.

Sponsored by

National Cancer Institute (NCI)

Purpose

This 2-phase study will determine the safety of treating patients with non-small cell lung cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed lung cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.

Patients 18 years of age or older with non-small cell lung cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, urinalysis, chest x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be obtained if needed.

Participants will receive four vaccinations a month apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the first year after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:

- Medical history and physical examination

- Blood tests

- X-rays and various scans (nuclear medicine/CT/MRI)

- FACT-L Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, before each vaccination, and during follow-up visits after completing the treatment. It includes questions on the severity of lung cancer symptoms and the ability to perform normal activities of daily life.

In addition to the above procedures, 3 skin punch biopsies will be done at the vaccination site to look for a local immune response. For this procedure, an area of skin is numbed with an anesthetic and a 4 mm (about 1/4-inch) circular area is removed, using a sharp cookie cutter-type instrument. Also, one blood sample per year will be collected for the next 15 years to monitor the safety of the gene transfer. Patients whose lung cancer spreads to the skin, superficial soft tissues, or a superficial lymph node may be asked to undergo a biopsy of the lesion to see what effect the treatment may be having on the tumor.

Condition  Treatment or Intervention Phase

Carcinoma, Non-Small-Cell Lung

  Drug: Hyperacute Lung Cancer Cell Vaccine

 Phase I

 MedlinePlus related topics:  Cancer

Study Type: Interventional

Study Design: Treatment, Safety

Official Title: A Phase I/II Study of an Antitumor Vaccination Using Alpha (1,3) Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Non-Small Cell Lung Cancer

Further Study Details:

According to statistics of the American Cancer Society, an estimated 169,400 individuals will be diagnosed with lung cancer and 154,900 will die of the disease this year despite all current therapy. This protocol attempts to exploit an approach to lung cancer gene therapy using a naturally occurring barrier to xenotransplantation in humans in attempt to vaccinate patients against their lung cancer. The expression of the murine alpha (1,3) galactosyltransferase [alpha (1,3) GT] gene results in the cell surface expression of alpha (1,3) galactosyl-epitopes (alpha-gal) on membrane glycoproteins and glycolipids. These epitopes are the major target of the hyperacute rejection response that occurs when organs are transplanted from non-primate donor species into man. Human hosts often have pre-existing anti-alpha-gal antibodies that bind alpha-gal epitopes and lead to rapid activation of complement and cell lysis. The pre-existing anti-alpha-gal antibodies found in most individuals are thought to be due to exposure to alpha-gal epitopes that are naturally expressed on normal gut flora leading to chronic immunological stimulation. These antibodies may comprise up to 1% of serum IgG. In this Phase I/II trial, patients with recurrent or refractory advanced stage non-small cell lung cancer will undergo a series of four intradermal injections with a trivalent vaccine composed of irradiated allogeneic non-small cell lung cancer cell lines (HAL-1, HAL-2 and HAL-3) that have been transduced with a recombinant Moloney murine leukemia virus (MoMLV)-based retroviral vector expressing the murine alpha (1,3) GT gene. Endpoints of the study include determination of dose-limiting toxicity (DLT), maximum tolerated dose (MTD), tumor and immunological responses.

Eligibility

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

Histological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma and large cell anaplastic lung carcinoma histologies are eligible. Bronchoalveolar carcinoma, mixed NSCLC/small cell lung carcinoma (SCLC) and variant large and small cell lung cancer are not eligible for this study. The patient's pathology must be reviewed by the NIH Clinical Center Department of Pathology.

AJCC Stage IV (any T, any N, M1), metastatic, or progressive or recurrent NSCLC. Patients may not be eligible for other curative intent treatment (e.g., surgical resection).

Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

Serum albumin greater than or equal to 3.0 gm/dL.

Expected survival greater than or equal to 4 months.

Adequate organ function including:

A. Marrow: Hemoglobin greater than or equal to 10.0 gm/dL, absolute granulocyte count (AGC) greater than or equal 1,500/mm(3), platelets greater than or equal to 100,000/mm(3), absolute lymphocyte count greater than or equal 475/mm(3).

B. Hepatic: Serum total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) less than or equal to 2.5 x ULN.

C. Renal: Serum creatinine (sCr) less than or equal to 1.5 x upper limit of normal, or creatinine clearance (Ccr) greater than or equal to 50 mL/min.

Measurable or non-measurable disease defined as:

Measurable - those that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques (CT, MRI, x-ray) or as greater than or equal to 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).

Non-measurable - All other lesions (or sites of disease), including small lesions (longest diameter less than 20 mm with conventional techniques or less than 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusions, lymphangitis cutis or pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), and cystic lesions are all considered non-measurable.

Subjects must have negative serologies for hepatitis viruses B and C, and HIV prior to entering study.

Prior therapy for NSCLC that may include surgery, radiation therapy, immunotherapy, and/or less than or equal to 2 different chemotherapy regimens (including neoadjuvant and adjuvant treatment).

Patients receiving preoperative (neoadjuvant) and postoperative (within 12 weeks of surgery) adjuvant chemotherapy with the same agent(s) will be considered to have received a single chemotherapy regimen.

Patients with previously treated, unresponsive or progressive disease that have failed at least one chemotherapy regimen.

Patients must be greater than or equal to 4 weeks since major surgery, radiotherapy, chemotherapy (6-weeks if they were treated with a nitrosourea or mitomycin) or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to less than or equal to Grade 1, exclusive of alopecia or fatigue.

Patients must have the ability to understand the study, its risks, side effects, potential benefits and is able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).

Male and female subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental drug, and for one month after the last immunization.

EXCLUSION CRITERIA:

Age less than 18-years-old.

Active CNS metastases or carcinomatous meningitis.

Hypercalcemia greater than 2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calctonin and/or bisphosphate therapy).

Pregnant or nursing women due to the unknown effects of vaccination on the developing fetus or newborn infant.

Other malignancy within five years, unless the probability of recurrence of the prior malignancy is less than 5%. Patient's curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.

History of organ transplant, active immunosuppressive therapy or history of prior immunotherapy.

Subjects taking systemic corticosteroid therapy and/or tacrolimus for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require systemic corticosteroids after beginning vaccinations, will be removed from the study.

Significant or uncontrolled congestive heart failure (CHF), myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.

Active infection or antibiotics within 1-week prior to study, including unexplained fever (temp. greater than 38.1 degrees Celsius).

Autoimmune disease (e.g., systemic lupus erythematosis, active rheumatoid arthritis, etc). Patients with a remote history of asthma or mild active asthma are eligible.

Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis).

Any condition, psychiatric or otherwise, that would preclude informed consent consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).

A known allergy to any component of the alpha (1,3) galactosyltransferase tumor vaccine or cell lines from which it is derived.

Expected Total Enrollment:  52

ABX-EGF (panitumumab)

Abgenix's most advanced antibody product candidate is ABX-EGF (panitumumab), a fully human monoclonal antibody generated using XenoMouse® technology.

ABX-EGF targets the epidermal growth factor receptor (EGFr), which is over-expressed in a variety of cancers including lung, breast, bladder, pancreatic, colorectal, kidney and head and neck cancer.  Research has demonstrated that cancer cells can become dependent on growth signals mediated through EGFr for their survival. In preclinical research, ABX-EGF monotherapy has been shown to inhibit the growth of human tumors in mice.

Codeveloped by Abgenix and Immunex, a wholly owned subsidiary of Amgen, ABX-EGF is being evaluated in a comprehensive clinical program in several indications. The program currently includes clinical trials to evaluate ABX-EGF in renal (kidney), colorectal, and non-small cell lung cancers. Results of clinical studies have demonstrated single-agent activity and a good pharmacokinetic and tolerability profile.

Clinical Development Program

Abgenix's fully human monoclonal antibody product candidate, ABX-EGF, is being tested in clinical trials as monotherapy and in combination with standard chemotherapy in several types of cancer. This program currently includes studies in renal, colorectal, and non-small cell lung cancers.

Abgenix and its partner Immunex, a wholly owned subsidiary of Amgen, are actively planning for commercialization of ABX-EGF, pending results of ongoing clinical studies. In January 2004, Amgen initiated pivotal clinical trials for ABX-EGF in third line colorectal cancer. Abgenix and Amgen expect further results from the ongoing phase 2 clinical program will emerge in 2004 and beyond. The companies continue to evaluate additional opportunities for ABX-EGF and plan to conduct further clinical studies.

Amgen Collaboration

Abgenix and Immunex, a wholly owned subsidiary of Amgen, are working together to develop and commercialize ABX-EGF (panitumumab) for various oncology indications. Abgenix and Amgen also have collaborative arrangements directed to other therapeutic antibody targets.

In October 2003, Immunex and Abgenix clarified responsibilities in the codevelopment agreement for ABX-EGF. Under the amended agreement, development costs are shared equally by the two companies, along with any future profits from product sales worldwide. Immunex will lead clinical development and commercialization activities, while Abgenix will be responsible for clinical and commercial manufacturing, with some assistance from Immunex . Abgenix also retains copromotion rights. Under the 2003 amendment, Immunex will make available to Abgenix $60 million in advances that may be used by Abgenix to fund its share of development and commercialization costs for ABX-EGF after Abgenix has contributed $20 million toward development costs in 2004. The amount of any advances drawn by Abgenix, plus interest, may be repaid out of profits resulting from future product sales. However, Abgenix is not obligated to repay any portion of the loan if ABX-EGF does not reach commercialization.

Key Product Characteristics

Results of ABX-EGF studies to date suggest several important differences between ABX-EGF and drugs targeting the EGF receptor and pathway:

ABX-EGF has not shown dose limiting toxicity, while the small-molecule drugs targeting the EGFr are dose-limited by the occurrence of severe diarrhea.

The current dose of ABX-EGF has been set at the level that results in 100% of patients achieving an acneiform skin rash that suggests full blockade of the EGFr on the skin.

Preliminary analysis of phase 2 studies suggests ABX-EGF has single-agent biological activity in patients with solid tumors.

ABX-EGF has demonstrated an extremely low incidence of immunologic reactions. In studies of over 500 patients, only two patients experienced infusion related reactions, in each case controllable by premedication.

EGF Receptor Inhibition

Relative to normal tissue, certain cancer cells that overexpress epidermal growth factor receptors (EGFr) on their surface often depend on EGFr's activation for growth.  EGFr is overexpressed in a variety of cancers, including lung, breast, ovarian, bladder, prostate, colorectal, kidney and head and neck.  EGFr activation is triggered by the binding of EGFr by EGF or transforming growth factor alpha (TGFa) and EGFr dimerization, which trigger the cellular signalings leading to tumor cell proliferation. EGF and TGF-a are expressed by the tumor or neighboring cells, which provide autocrine and parocrine growth support for tumor growth.  

ABX-EGF is being developed based on the belief that blocking the ability of EGF and TGFa to bind with EGFr offers a potential treatment strategy for certain cancers.  ABX-EGF, a fully human monoclonal antibody generated using XenoMouse technology, binds to EGFr with high affinity. This antibody has been shown to inhibit tumor cell proliferation in mouse models and cause eradication of EGF-dependent human tumors in mice.

Abgenix is conducting preclinical studies and assessing which cancer types may be eligible for ABX-EGF treatment. Published studies have shown that ABX-EGF can inhibit growth of EGF-dependent human tumors cells in mouse models. ABX-EGF has also been shown to eradicate established tumors in mice, even when administered after significant tumor growth has occurred.

 Abgenix Reports Encouraging Preclinical Results With ABX-EGF In Cancer Research

Fully Human Antibody Eradicates Established Tumors as Monotherapy

FREMONT, Calif., March 15, 1999 -- Abgenix, Inc. (Nasdaq: ABGX) reported today in Cancer Research (Volume 59, Issue no. 6), encouraging results of preclinical studies with its proprietary fully human monoclonal antibody, ABX-EGF. Developed using the company's XenoMouseTM technology, ABX-EGF targets the receptor for human epidermal growth factor (EGFr) which is overexpressed on many major human tumor types including renal, prostate, colorectal, head and neck, and breast. As reported in a paper titled, "Eradication of Established Tumors by a Fully Human Monoclonal Antibody to the Epidermal Growth Factor Receptor without Concomitant Chemotherapy," Abgenix scientists demonstrated that ABX-EGF alone, in mouse models, can both block the growth of human tumors, is potent at comparatively low doses and, more importantly, eradicates established tumors. Another member of the EGFr family, Her-2, is the target for a monoclonal antibody currently being marketed by Genentech, Inc. for treatment of breast cancer.

With cancer cells, expression of EGFr is significantly increased, which increases growth stimuli and causes cells to divide abnormally. Consequently, many cancer cells require EGFr for their survival. ABX-EGF binds with high affinity to the EGFr and selectively targets these cancer cells by blocking the binding of important tumor growth factors to the receptor. A key finding of the Abgenix studies was that relatively low doses of ABX-EGF, without concomitant chemotherapy, could eradicate human tumors with a size of up to 1.2cm3 in mice. Although the treatment period was relatively short, no recurrence of tumors was seen in these mice out to 250 days after the last dose of antibody. Abgenix plans to begin clinical trials with ABX-EGF around midyear.

"We believe that these results indicate the potential of ABX-EGF as a monotherapy for the treatment of multiple EGF-dependent human solid tumors, including those for which no effective chemotherapy is available," stated R. Scott Greer, president and chief executive officer of Abgenix. "Because EGFr is overexpressed on many types of cancer, ABX-EGF has the potential to be a broad cancer treatment."

As a fully human antibody generated with XenoMouseTM technology, ABX-EGF is expected to have minimal immunogenicity and a longer half-life than antibody products containing mouse protein, thus potentially allowing repeat administration at lower doses in patients with competent immune systems. This potential was observed in a Phase I clinical trial in psoriasis of ABX-IL8, the first fully human antibody generated in transgenic mice to be tested in humans. ABX-IL8 demonstrated a three week half life, equivalent to that of naturally occuring human antibodies and no immune reaction to ABX-IL8 was observed.

Abgenix is a biopharmaceutical company that develops and intends to commercialize antibody therapeutic products for the treatment of a variety of disease conditions, including transplant-related diseases, inflammatory and autoimmune disorders, cardiovascular disease and cancer. Abgenix has developed XenoMouse technology, which it believes enables quick generation of high affinity, fully human antibody product candidates to essentially any disease target appropriate for antibody therapy. Abgenix has collaborative arrangements with multiple pharmaceutical and biotechnology companies involving its XenoMouse technology. In addition, Abgenix has four proprietary antibody product candidates that are under development internally, two of which are in human clinical trials.

Statements made in this press release about the potential of ABX-EGF as a monotherapy, Abgenix's XenoMouse technology, product development activities and collaborative arrangements other than statements of historical fact, are forward looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements and the extent and breadth of Abgenix's patent portfolio. Please see Abgenix's public filings with the Securities and Exchange Commission for information about risks which may affect Abgenix.

Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer

This study is currently recruiting patients.

Sponsored by

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

 Purpose

RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.

Condition  Treatment or Intervention Phase

Colorectal Cancer

Esophageal Cancer

kidney tumor

Lung Cancer

Pancreatic Cancer

Prostate Cancer

  Drug: monoclonal antibody ABX-EGF

 Procedure: antibody therapy

 Procedure: biological response modifier therapy

 Procedure: monoclonal antibody therapy

 Phase I

 MedlinePlus related topics:  Colorectal Cancer;   Esophageal Cancer;   Kidney Cancer;   Lung Cancer;   Pancreatic Cancer;   Prostate Cancer

Study Type: Interventional

Study Design: Treatment

Official Title: Phase I Study of Monoclonal Antibody ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small Cell Lung, Colorectal, Esophageal, or Gastroesophageal Junction Cancer

Further Study Details:

OBJECTIVES:

Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer.

Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population.

Evaluate the clinical effect of this drug in this patient population.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5.

NOTE: *All patients receive a total of 4 doses.

Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity.

Patients are followed every 2 weeks for 5 weeks.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:

Renal cell cancer (RCC)

Prior nephrectomy required

Prostate cancer

Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)

Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)

Pancreatic cancer

Failed at least 1 prior standard therapy regimen for unresectable metastatic disease

Non-small cell lung cancer

Failed at least 1 prior standard therapy regimen for unresectable metastatic disease

Colorectal cancer

Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease

Esophageal cancer

Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)

Gastroesophageal junction cancer

Evaluable disease

Epidermal growth factor receptor overexpression

Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells

No uncontrolled brain metastases

No evidence of disease progression or regression after a 30-day washout period

PATIENT CHARACTERISTICS: Age:

18 and over

Performance status:

Karnofsky 70-100% OR

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count greater than 1,000/mm^3

Platelet count greater than 100,000/mm^3

Hepatic:

AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)

Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)

Renal:

Creatinine less than 2.2 mg/dL

NCI renal toxicity no greater than grade 2

No hypercalcemia (antihypercalcemic therapy allowed)

Cardiovascular:

Ejection fraction at least 45% by MUGA

No abnormal ECG or MUGA

No myocardial infarction within the past year

Pulmonary:

No abnormal chest x-ray

FEV_1 greater than 50% of predicted

Other:

No known allergy to ingredients of study drug

No known allergy to Staphylococcus aureus Protein A

HIV negative

No chronic medical or psychiatric condition that would preclude study compliance

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)

No other concurrent biologic therapy

Chemotherapy:

See Disease Characteristics

At least 6 weeks since prior chemotherapy and recovered

No prior chemotherapy for RCC

No prior anthracyclines

No concurrent chemotherapy

Endocrine therapy:

See Disease Characteristics

Concurrent steroids allowed

Concurrent hormonal therapy allowed

Radiotherapy:

See Disease Characteristics

No prior mediastinal radiotherapy

No concurrent radiotherapy

Surgery:

See Disease Characteristics

Recovered from any recent prior surgery

Other:

At least 30 days since prior investigational drug or device

At least 30 days since prior systemic therapy

No other concurrent investigational drugs

No other concurrent systemic agents or cancer therapy

Drugs Approved by the FDA Drug Name: CEA-Scan

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Immunomedics

Approval Status: Approved April 1996

Treatment for: colorectal cancer

General Information

CEA is expressed by more than 90% of colorectal cancers, as well as by a large number of other carcinomas, including esophageal, stomach, lung, breast, pancreas, uterus, and ovarian cancer. It has been shown that this tumor marker can serve as a useful target for radiolabeled antibodies. Since CEA-Scan uses a small antibody fragment at a low dose, there is virtually no immune reaction by subjects to the foreign protein. In addition, linking the fragment with technetium-99m, a common radioisotope in nuclear medicine, permits tumor detection within a few hours, using conventional gamma cameras.

Mechanism of Action

CEA-Scan comprises an antibody fragment (Fab') against the tumor marker, carcinoembryonic antigen ("CEA").

Additional Information

Each year there are approximately 134,000 new cases of colorectal cancer in the United States; colorectal cancer is estimated to kill over 55,000 Americans annually. Trials are also under way for lung and breast cancer indications.

Drug listing last updated on October 26, 2001

Clinical Overview  

Immunomedics has a broad clinical research program involving diagnostic imaging and therapeutic agents. The Company is unique in having companion imaging and therapeutic agents based upon similar antibodies and disease indications (Table 1). For example, CEA-Scan® (arcitumomab) targets cancers expressing carcinoembryonic antigen (CEA), which comprise about 80 percent of all solid cancers, and is currently approved in the U.S., Canada, and Europe, for the detection of colorectal cancer spread, in conjunction with other standard diagnostic tests. Publications in the medical literature have also shown that CEA-Scan can image lung and breast cancers.

CEA-Cide (labetuzumab) is the therapeutic counterpart, also involving a specific antibody against CEA, but in this case the antibody has been humanized, a process that depletes by about 90% all murine components in the antibody by replacement with human immunoglobulin, or antibody, structures. This antibody is in clinical studies as a naked (unlabeled) and a radiolabeled conjugate, for the therapy of diverse cancers expressing CEA, including colorectal, pancreatic and breast cancers. The Company believes that the therapeutic use of CEA-Cide may create a market interest in the use of CEA-Scan for improved patient management, such as earlier staging of cancer and earlier identification of residual disease following therapy.

Another example of companion imaging and therapy products is LymphoScan® ~ LymphoCide. LymphoScan consists of the fragment of an antibody against the CD22 determinant on B-cells, and targets B-cell tumors, such as non-Hodgkin's lymphoma (NHL). The product is in Phase III trials to stage NHL patients and to assess residual disease following therapy.

A humanized version of this antibody constitutes LymphoCide (epratuzumab), which is being studied clinically both as a naked (unlabeled) and a radiolabeled (yttrium-90 or 90Y) form. The unlabeled epratuzumab is now entering Phase III trials for the therapy of NHL, while the 90Y-version is in Phase I trials.

Imaging Therapy Potential Disease Target

 CEA-Scan  CEA-Cide

 Stomach, colorectal, pancreatic,

medullary thyroid, head/neck, lung,

breast, ovarian, uterine, bladder

cancers

 LymphoScan  LymphoCide

 Non-Hodgkin's lymphoma

 AFP-Scan  AFP-Cide

 Liver and germ-cell cancers

(testis and ovary)

 MyelomaScan  MyelomaCide

 Multiple Myeloma

 LeukoScan LeukoCide

 Infection imaging /

Acute and chronic myeloid leukemia

 ProstaScan

 ProstaCide

 Prostate cancer

Clinical Development of a Novel Cancer Vaccine: A Multi-Epitope Vaccine for Lung and Colorectal Cancer

 Introduction/Background

In order to create multi-epitope cancer vaccines, Epimmune has developed a highly efficient strategy which can be applied universally to tumour-associated antigens for the identification of cytotoxic T cell and helper T cell epitopes, the know-how for modifying epitopes to create analogues with enhanced immunogenicity, and proprietary methods to optimally configure these epitopes for delivery using DNA, viral or recombinant protein delivery strategies.

Aims/Hypothesis

Epimmune's EP-2101 is in development as a breast, colon and lung cancer vaccine constructed with natural and modified epitopes derived from four well-characterised, tumour-associated antigens, CEA, HER2/neu, p53 and MAGE 2/3.

Research

Delivered as synthetic peptides in adjuvant, EP-2101 includes PADRE®, Epimmune's proprietary T cell epitope, to improve the immunogenicity of disease-specific epitopes. The epitopes utilised in EP-2101 are the actual peptides responsible for the induction of an anti-cancer immune response, which increases both safety and potency of the vaccine as compared to vaccines using whole antigens or poorly defined, cell-derived antigen mixtures. Additionally, EP-2101 includes multiple epitope analogues modified to increase immune response potency, a competitive advantage facilitated by the epitope approach. EP-2101 is appropriate for treatment of HLA-A2 patients, which represent approximately 45% of most ethnic groups.

Epimmune Inc. received clearance from the United States Food and Drug Administration to start Phase I/II clinical trials of its EP-2101 therapeutic, multi-epitope vaccine in lung and colorectal cancer patients. Two separate Phase I/II trials are currently being conducted, one in colorectal cancer and one in non-small cell lung cancer, at various sites in the US. The trials involve an aggregate of approximately 25 patients who have had surgery to remove the majority of the cancer cells. These patients generally have normal immune system function. The vaccine candidate includes proprietary, native epitopes as well as a number of modified, or analogue, epitopes that are designed to enhance the potency of the T cell response. Primary endpoints of the trials will be safety and immunogenicity, as measured by the quantity and breadth of cytotoxic T cells, or CTLs generated. Safety and immunogenicity results from the current trials are expected in the first half of 2004.

Conclusion

A novel multi-epitope vaccine is undergoing Phase I/II clinical development for lung and colorectal cancer.

Relevance/Opportunity

Epimmune is seeking licensing and collaborative partnership opportunities with companies interested in the development of T cell epitope-based vaccines for the treatment of colorectal and non-small cell lung cancer. The opportunity for EP-2101 also includes access to Epimmune's second-generation epitope package. Derived from the same four tumour-associated antigens this clinical research-stage epitope portfolio targets multiple HLA supertypes for universal patient population coverage. Please enquire below if you are interested in this opportunity.

Epimmune gets FDA okay to start studies of cancer vaccines

Reuters Health Posting Date: January 13, 2003 Last Updated: 2003-01-13 15:19:10 -0400 (Reuters Health)

WASHINGTON (Reuters Health) - Epimmune Inc. said on Monday that it has received clearance from the US Food and Drug Administration (FDA) to start phase I/II clinical trials of its EP-2101 therapeutic, multi-epitope vaccine in lung and colorectal cancer patients.

The company said that it plans to conduct two separate trials for the individual indications, involving an aggregate of approximately 25 patients who have had surgery to remove the majority of the tumor. These patients generally have normal immune system function, the company noted.

Assuming patient enrollment proceeds on schedule, Epimmune said the first patients are expected to begin treatment in approximately four weeks and the final data analysis is expected to be complete in the first half of 2004. The company said the primary endpoints of the trials would be safety and immunogenicity, as measured by the quantity and breadth of cytotoxic T cells generated.

According to Epimmune, EP-2101 includes proprietary, native epitopes and a number of modified, or analog, epitopes that were designed to enhance the potency of the T cell response.

Cell Genesys' GVAX® lung cancer vaccine is a patient-specific vaccine designed to induce a systemic immune response against the patient's lung cancer. The vaccine is made by directly modifying the patient's tumor cells using a semi-automated closed system designed to enable safe and sterile manufacturing of each patient's vaccine. After surgical removal of a patient's tumor, the GVAX® cancer vaccine is prepared by culturing and genetically modifying the patient's tumor cells to secrete GM-CSF, an immune stimulatory hormone. The cells are then irradiated for safety prior to vaccinating the patient.

Based on encouraging data from the companys initial trial of GVAX® lung cancer vaccine, Cell Genesys will conduct two Phase 2 clinical trials evaluating GVAX® lung cancer vaccine. The first of these Phase 2 trials, initiated in April 2003, is sponsored by Cell Genesys and is enrolling patients with all subtypes of non small-cell lung cancer. Patients are being randomized to receive GVAX® lung cancer vaccine with or without low-dose cyclophosphamide, a chemotherapeutic agent which in the doses to be employed has been shown to enhance the immune response. The second Phase 2 trial, which is expected to be sponsored and partially funded by the Southwest Oncology Group (SWOG), a cooperative clinical trials group of the National Cancer Institute (NCI), will focus on patients with the bronchoalveolar carcinoma (BAC) subtype of non small-cell lung cancer. This trial is expected to begin in the second quarter of 2004. The two trials may enroll up to approximately 75 patients each.

At the International Conference on Gene Therapy of Cancer in December 2002, final data were reported from the company's initial Phase 1/2 trial of GVAX® lung cancer vaccine in patients with advanced non small-cell lung cancer. Patients received the treatment vaccine in an outpatient clinical setting over a three-month period and were monitored for the subsequent six months. Of the 33 advanced stage patients, most of whom had failed prior chemotherapy and/or radiation therapy, three patients (9 percent) experienced complete responses (complete disappearance of all tumors) with a median duration of response of 17.8 months. The median survival of all 33 treated patients was 11.6 months (measured from the initiation of vaccine manufacturing), which compares favorably to the approved second-line taxane chemotherapy for such patients. Of these three patients, two were noted to have the BAC subtype of lung cancer. In addition to these complete responses, seven patients (21 percent) achieved stable (non progressive) disease with a median response duration of 7.7 months. Median survival was significantly longer in patients whose vaccine products secreted higher levels of GM-CSF which all GVAX® vaccines are engineered to produce (median survival of 17.1 months for GM-CSF >40 ng./106 cells/24 hr. versus median survival of 7.4 months for GM-CSF <40ng./106 cells/24 hr., p= .04).

Cell Genesys constructed a 35,000 square-foot manufacturing facility in Memphis, TN, which is being used for the manufacturing of the company's patient-specific GVAX® lung cancer vaccines for the ongoing Phase 2 clinical trial, and is also expected to be used for the Phase 3 clinical trial and potential market launch.

(The data referenced in the preceding paragraphs represent the most recently announced data pertaining to this program.)

Information About GVAX® Lung Cancer Vaccine Clinical Trials Currently Under Way:

D-0031: A Phase 2 Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) ("GVAX® Lung Cancer Vaccine") with and without Low-Dose Cyclophosphamide in Advanced Stage Non Small-Cell Lung Cancer.

Cell Genesys, Inc. (CEGE) Reacquires Full Commercial Rights To GVAX Lung Cancer Vaccines From Japan Tobacco; License Agreement Terminated

FOSTER CITY, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced that the company has reacquired full commercial rights to GVAX® lung cancer vaccines following the termination of its remaining license agreement with the pharmaceutical division of Japan Tobacco Inc. (JT). As a result, Cell Genesys now holds all worldwide commercial rights to its entire portfolio of GVAX® cancer vaccine products. Given the scope of the company's plans for the next clinical trials of GVAX® lung cancer vaccine, as well as the anticipated funding from the National Cancer Institute for one of those trials, Cell Genesys expects the near-term revenue impact from ending the agreement with JT to be minimal.

"We believe that holding full commercial rights to all of our GVAX® cancer vaccines, particularly as these products advance toward Phase III trials, will enhance our flexibility in pursuing an optimal worldwide commercialization strategy for GVAX® products," stated Robert H. Tidwell, senior vice president, corporate development of Cell Genesys. "We, of course, appreciate JT's support during the early phase of our GVAX® cancer vaccine program and understand their business circumstances which have led to this decision."

In June of this year at the International Lung Cancer Congress, Cell Genesys presented the final results of a multicenter Phase I/II trial of GVAX® lung cancer vaccine. These results demonstrated complete tumor regressions in three of 33 patients (nine percent) with advanced non small- cell lung cancer (NSCLC) who received the vaccine after failing prior radiation and/or chemotherapy, as well as stable disease or minor responses in another seven patients (21 percent). The median survival of all treated patients was approximately eight months compared to 5.7 - 7 months reported for taxol chemotherapy and approximately 4.6 months for best supportive care. In addition, patients with the bronchoalveolar carcinoma (BAC) subtype of NSCLC appeared to be particularly responsive to GVAX® lung cancer vaccine treatment. As a result, the company recently announced its intention to conduct two Phase II trials in patients with BAC prior to initiating a broad Phase III trial in all types of NSCLC. One of the two BAC trials will be sponsored and conducted by the National Cancer Institute's Southwest Oncology Group (SWOG). Both BAC studies are expected to begin in the late 2002/early 2003 timeframe. A Phase III study of all types of NSCLC is targeted to begin in late 2003.

Cell Genesys and JT entered into the collaboration agreement for GVAX® cancer vaccines in December 1998. The agreement, which originally focused on the development of GVAX® prostate cancer and lung cancer vaccines, was significantly reduced in scope in November 2001 to focus primarily on GVAX® lung cancer vaccines. Under the modified agreement, Cell Genesys would pay JT an undisclosed royalty on GVAX® lung cancer vaccine sales in all territories except Japan, Taiwan and Korea where JT would pay the same royalty to Cell Genesys, and JT would provide partial development funding for GVAX® lung cancer vaccine products.

Cell Genesys' GVAX® cancer vaccines are comprised of tumor cells which have been irradiated and genetically modified to secrete granulocyte- macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines. The genetically modified tumor cells are used to vaccinate patients to stimulate an immune response against their tumor. GVAX® cancer vaccines have demonstrated antitumor effects against every type of human cancer against which they have been tested to date. Currently, Cell Genesys is evaluating non patient- specific, off-the-shelf GVAX® vaccines for prostate cancer and pancreatic cancer and patient-specific, individualized vaccines for lung cancer, leukemia and myeloma. With all tumor types and vaccine formats tested, GVAX® cancer vaccines have demonstrated a favorable side effect profile and have been safely administered to over 400 patients to date. GVAX® prostate cancer vaccine, Cell Genesys' lead product candidate, is expected to enter Phase III clinical trials by mid-2003.

Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms -- GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. Cell Genesys is headquartered in Foster City, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.

Statements made herein about Cell Genesys and its subsidiaries, other than statements of historical fact, including statements about the progress and reports of clinical trials, timelines and future plans for clinical programs, marketability and success of potential products and nature of product pipelines, licensing agreements, partnering expectations and revenue expectations are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of research and development programs, the success and results of clinical trials, the regulatory approval process, competitive technologies and products, patents and additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated April 1, 2002 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.

Cell Genesys reports antitumor activity in Phase I/II GVAX lung cancer vaccine trial

SAN FRANCISCO, Calif., May 13, 2001Cell Genesys, Inc. (Nasdaq: CEGE) today reported interim clinical data from its multicenter Phase I/II GVAX® lung cancer vaccine trial which demonstrates objective evidence of antitumor activity including a major response rate of 18 percent in patients with advanced non small-cell lung cancer who have failed chemotherapy and/or radiation therapy. These data were presented on behalf of the GVAX® Lung Cancer Clinical Investigators by John Nemunaitis, M.D. of U.S. Oncology at the American Society of Clinical Oncology (ASCO) Meeting in San Francisco, Calif. The presentation was one of 17 selected for ASCOs Official Press Program from the more than 3,300 submitted to the meeting.

The interim clinical trial data includes results on 30 currently evaluable patients with advanced or early-stage lung cancer. Of 22 patients with advanced-stage lung cancer, three patients, two of whom had failed chemotherapy and one who failed radiation therapy, showed a complete disappearance of metastatic tumors following treatment with GVAX® lung cancer vaccine. One other patient who failed radiation and chemotherapy had partial (greater than 50 percent) reduction in his tumor. In addition to these major responses, four patients currently have stable (non-progressive) disease. All of these responses are continuing with a median follow-up time of approximately five months. In addition to the responses in patients with advanced disease, seven of eight patients with early-stage lung cancer who received GVAX® vaccine following surgery, currently remain free of disease with a median follow-up time of seven months.

We are very encouraged by what we have seen to date with GVAX® lung cancer vaccine, particularly with respect to the major tumor responses in patients with metastatic lung cancer who have failed chemotherapy, stated Dr. Nemunaitis. These findings are all the more noteworthy given that lung cancer patients who fail chemotherapy have little chance of responding to further chemotherapy or other treatment.

These exciting clinical results with our GVAX® lung cancer vaccine are yet another reason we have increased our investment in the clinical and manufacturing development required to bring a GVAX® product to market, stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer of Cell Genesys. GVAX® vaccines have demonstrated objective evidence of antitumor activity in all five types of cancer in which they have been testedlung, prostate, pancreatic, kidney and melanomaas well as a very favorable safety profile compared to chemotherapy which has been documented in over 300 patients treated to date.

The currently ongoing Phase I/II trial of GVAX® lung cancer vaccine for which the interim results were reported has recently completed enrollment. A final report on the trial is expected during the next year. In this trial, patients were administered up to six vaccine treatments every other week for three months as an intradermal (under the skin) injection. Patients received no other anticancer treatments during the trial evaluation period. As has been demonstrated in all GVAX® cancer vaccine trials to date, the vaccine was shown to be safe and well tolerateda side effect profile which compares favorably to other cancer treatments such as chemotherapy. No dose limiting toxicities have been observed. In addition to the antitumor activity noted above, the interim trial results also demonstrate that GVAX® lung cancer vaccine induces an anti-lung cancer cellular immune response as well as the formation of new anti-lung cancer antibodies in the blood.

Update on Initial Trial of GVAX® Lung Cancer Vaccine

An earlier Phase I/II trial of GVAX® lung cancer vaccine in patients with advanced non small-cell lung cancer which was conducted by Dr. Glenn Dranoff and colleagues at Dana-Farber/Partners Cancer Care, an affiliate of Harvard Medical School, was reported at the Ninth World Conference on Lung Cancer in Tokyo, Japan in September 2000. This trial demonstrated antitumor immunity in 18 of 25 patients. In addition, two patients who received GVAX® lung cancer vaccine following surgery remain in complete remission more than three years after GVAX® treatment.

Future Clinical Trials for GVAX® Lung Cancer Vaccine

The GVAX® lung cancer vaccine trials to date, including the current study, have employed a patient-specific product format in which the vaccine is directly prepared from the patients own tumor cells in an overnight process. In the near future, Cell Genesys plans to launch a clinical trial in advanced lung cancer to evaluate a non patient-specific GVAX® product which will be centrally manufactured by Cell Genesys and then mixed with patients own irradiated tumor cells prior to vaccination. This new product format for GVAX® lung cancer vaccine is expected to have significant development and commercialization advantages compared to the first generation product used in the trial reported today. Given the encouraging results demonstrated in ongoing clinical trials for prostate and pancreatic cancer, Cell Genesys is emphasizing non patient-specific GVAX® products which can be developed and commercialized as off-the-shelf pharmaceuticals.

Background on GVAX® Cancer Vaccines

GVAX® cancer vaccines are comprised of tumor cells which have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines. The genetically modified tumor cells are then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor. The company's lead GVAX® cancer vaccine program targets patients with recurrent hormone refractory prostate cancer and is currently being evaluated in two multicenter Phase II trials. A series of Phase I/II trials was recently initiated utilizing the companys new high-potency GVAX® prostate cancer vaccine. Additionally, a Phase I/II trial for GVAX® vaccine for myeloma was recently initiated, and a Phase II trial of GVAX® pancreatic cancer vaccine and a Phase I/II trial of GVAX® vaccine for leukemia are expected to commence in mid 2001.

Cell Genesys Profile

Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major, life-threatening diseases. The company is conducting clinical trials of GVAX® cancer vaccines in prostate cancer, pancreatic cancer, lung cancer and myeloma and expects to initiate new studies in acute leukemia during 2001. Preclinical stage programs include gene therapies for cancer, hemophilia and cardiovascular disorders. Cell Genesys majority-owned subsidiary, Ceregene, is focused on gene therapies for central nervous system disorders. Cell Genesys also continues to hold a 10.5 percent equity interest in its former subsidiary, Abgenix, an antibody product company. For additional information, please visit the company's web site at www.cellgenesys.com.

Promising Lung Cancer Vaccine Trial Results Reported

A lung cancer vaccine Phase I/II trial that demonstrates objective evidence of antitumor activity was announced Sunday. The activity reported included a major response rate of 18 percent in patients with advanced non small-cell lung cancer who had failed chemotherapy and/or radiation therapy.

The data were presented on behalf of Cell Genesys, Inc. GVAX® Lung Cancer Clinical Investigators by John Nemunaitis, M.D. of U.S. Oncology at the American Society of Clinical Oncology (ASCO) Meeting in San Francisco, Calif.

The presentation was one of 17 selected, from the more than 3,300 submitted to the meeting, for ASCO's Official Press Program.

The interim clinical trial data includes results on 30 currently evaluable patients with advanced or early-stage lung cancer. Of 22 patients with advanced-stage lung cancer, three patients, two of whom had failed chemotherapy and one who failed radiation therapy, showed a complete disappearance of metastatic tumors following treatment with GVAX® lung cancer vaccine.

One other patient who had failed radiation and chemotherapy had partial (greater than 50 percent) reduction in his tumor. In addition to these major responses, four patients currently have stable (non-progressive) disease.

All of these responses are continuing, with a median follow-up time of approximately five months. In addition to the responses in patients with advanced disease, seven of eight patients with early-stage lung cancer who received GVAX® vaccine following surgery currently remain free of disease, with a median follow-up time of seven months.

"We are very encouraged by what we have seen to date with GVAX® lung cancer vaccine, particularly with respect to the major tumor responses in patients with metastatic lung cancer who have failed chemotherapy," stated Dr. Nemunaitis. "These findings are all the more noteworthy given that lung cancer patients who fail chemotherapy have little chance of responding to further chemotherapy or other treatment."

"These exciting clinical results with our GVAX® lung cancer vaccine are yet another reason we have increased our investment in the clinical and manufacturing development required to bring a GVAX® product to market," stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer of Cell Genesys.

Dr. Vallmer added, "GVAX® vaccines have demonstrated objective evidence of antitumor activity in all five types of cancer in which they have been tested -- lung, prostate, pancreatic, kidney and melanoma -- as well as a very favorable safety profile compared to chemotherapy, which has been documented in over 300 patients treated to date."

The currently ongoing Phase I/II trial of GVAX® lung cancer vaccine has recently completed enrollment. A final report on the trial is expected during the next year.

In this trial, patients were administered up to six vaccine treatments every other week for three months as an intradermal (under the skin) injection. Patients received no other anticancer treatments during the trial evaluation period.

As has been demonstrated in all GVAX® cancer vaccine trials to date, the vaccine was shown to be safe and well tolerated -- a side effect profile that compares favorably to other cancer treatments such as chemotherapy. No dose-limiting toxicities have been observed.

In addition to the antitumor activity noted above, the interim trial results also demonstrate that GVAX® lung cancer vaccine induces an anti-lung cancer cellular immune response and formation of new anti-lung cancer antibodies in the blood.

An earlier Phase I/II trial of GVAX® lung cancer vaccine in patients with advanced non small-cell lung cancer, conducted by Dr. Glenn Dranoff and colleagues at Dana-Farber/Partners Cancer Care, an affiliate of Harvard Medical School, was reported at the Ninth World Conference on Lung Cancer in Tokyo, Japan in September 2000.

This trial demonstrated antitumor immunity in 18 of 25 patients. In addition, two patients who received GVAX® lung cancer vaccine following surgery remain in complete remission more than three years after GVAX® treatment.

The GVAX® lung cancer vaccine trials to date, including the current study, have employed a patient-specific product format in which the vaccine is prepared directly from the patient's own tumor cells in an overnight process.

In the near future, Cell Genesys plans to launch a clinical trial in advanced lung cancer to evaluate a non patient-specific GVAX® product which will be centrally manufactured by Cell Genesys and then mixed with patients' own irradiated tumor cells prior to vaccination.

This new product format for GVAX® lung cancer vaccine is expected to have significant development and commercialization advantages compared to the first-generation product used in the trial reported yesterday.

Given the encouraging results demonstrated in ongoing clinical trials for prostate and pancreatic cancer, Cell Genesys is emphasizing non patient-specific GVAX® products which can be developed and commercialized as "off-the-shelf" pharmaceuticals.

GVAX® cancer vaccines are comprised of tumor cells which have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines.

The genetically modified tumor cells are then irradiated for safety and used to vaccinate patients to stimulate an immune response against their tumor.

The company's lead GVAX® cancer vaccine program targets patients with recurrent hormone refractory prostate cancer and is currently being evaluated in two multicenter Phase II trials.

A series of Phase I/II trials was recently initiated utilizing the company's new high-potency GVAX® prostate cancer vaccine. Additionally, a Phase I/II trial for GVAX® vaccine for myeloma was recently initiated, and a Phase II trial of GVAX® pancreatic cancer vaccine and a Phase I/II trial of GVAX® vaccine for leukemia are expected to commence in mid 2001.

Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major life-threatening diseases. The company is conducting clinical trials of GVAX® cancer vaccines in prostate cancer, pancreatic cancer, lung cancer and myeloma and expects to initiate new studies in acute leukemia during 2001.

Preclinical stage programs include gene therapies for cancer, hemophilia and cardiovascular disorders. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for central nervous system disorders. Cell Genesys also continues to hold a 10.5 percent equity interest in its former subsidiary, Abgenix, an antibody product company.

A Phase I and Pharmacokinetic Study of ILX-295501, an Oral Diarylsulfonylurea, on a Weekly for 3 Weeks Every 4-Week Schedule in Patients with Advanced Solid Malignancies

The recommended dose for Phase II studies of the oral DSU ILX-295501 administered weekly for 3 weeks every 4 weeks is 1000 mg/m(2)/day for both minimally pretreated and HP patients. The characteristics of the myelosuppressive effects of ILX-295501, the paucity of severe nonhematological toxicities, and preliminary antitumor activity warrant disease-directed evaluations of ILX-295501.

A Phase I and Pharmacokinetic Study of ILX-295501,1 an Oral Diarylsulfonylurea, on a Weekly for 3 Weeks Every 4-Week Schedule in Patients with Advanced Solid Malignancies

Purpose: This study was conducted to assess the feasibility of administering the oral diarylsulfonylurea (DSU) ILX-295501 on a weekly for 3 weeks every 4-week schedule. The study also sought to determine the maximum tolerated dose (MTD) of ILX-295501 on this schedule, characterize its pharmacokinetic behavior, and seek preliminary evidence of anticancer activity.

Experimental Design: The initial starting dose of ILX-295501 was 100 mg/m2, which was equivalent to one-sixth of the highest dose that did not induce irreversible toxicity in dogs, and, using a modified Fibonnaci search scheme to guide dose level selection, the following dose levels were evaluated: 100, 200, 400, 600, 900, 1350, and 1800 mg/m2. Because severe toxicities were being reported in other trials at doses that encompassed this range and a cumulative toxicity profile was emerging, the study was suspended and then reinitiated to further reevaluate the lower dosing range. In the second part of the study, the following dose levels were selected a priori for evaluation: 400, 800, 1000, 1250, and 1500 mg/m2; and a modified continual reassessment model was used for dose assignment to determine the MTD, which was defined a priori as the highest dose in which the incidence of dose-limiting toxicity in the first course did not exceed 20%.

Results: Forty-nine patients were treated with 142 courses of ILX-295501 at doses ranging from 100 to 1800 mg/m2. The incidences of dose-limiting toxicity, principally neutropenia and thrombocytopenia, were unacceptably high at ILX-295501 doses exceeding 1000 mg/m2, which was determined to be the MTD for both minimally pretreated and heavily pretreated (HP) patients. In contrast to the first generation of DSUs, particularly sulofenur, clinically relevant levels of oxidized hemoglobin (methemoglobin) and secondary hemolytic anemia, were not noted. One HP patient with non-small cell lung carcinoma experienced a partial response. Pharmacokinetic studies revealed that ILX-295501 was absorbed slowly, with peak plasma concentrations (Cmax) achieving 6.02 h, on average, after oral administration. The pharmacokinetic behavior of ILX-295501 was characterized by dose proportionality, a relatively small apparent volume of distribution at steady state (Vss/F), averaging 8.02 ± 14.08 liters, and low apparent total body clearance (CLt/F) rate (mean, 0.036 ± 0.116 liters/h). The initial drug distribution phase was rapid [harmonic mean half-life (t1/2), 2.1 ± 7.0 min], whereas the terminal elimination phase was slow (harmonic mean t1/2ß, 150.6 ± 80.2 h).

Conclusions: The recommended dose for Phase II studies of the oral DSU ILX-295501 administered weekly for 3 weeks every 4 weeks is 1000 mg/m2/day for both minimally pretreated and HP patients. The characteristics of the myelosuppressive effects of ILX-295501, the paucity of severe nonhematological toxicities, and preliminary antitumor activity warrant disease-directed evaluations of ILX-295501.

Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer

This study is currently recruiting patients.

Sponsored by

Dana-Farber/Harvard Cancer Center

National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer.

Condition  Treatment or Intervention Phase

acute leukemia

atypical chronic myeloid leukemia

Melanoma

myelodysplastic and myeloproliferative disease

Non-small cell lung cancer

ovarian epithelial cancer

  Drug: anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

 Procedure: antibody therapy

 Procedure: biological response modifier therapy

 Procedure: monoclonal antibody therapy

 Procedure: non-tumor cell derivative vaccine

 Procedure: vaccine therapy

 Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lung Cancer;   Melanoma;   Ovarian Cancer;   Respiratory Diseases

Study Type: Interventional

Study Design: Treatment

Official Title: Phase I Pilot Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody (MDX-CTLA4) in Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, or Non-Small Cell Lung Cancer Previously Treated With Sargramostim (GM-CSF)-Based Autologous Tumor Vaccine

Further Study Details:

OBJECTIVES:

Determine the safety of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndromes, or non-small cell lung cancer previously treated with sargramostim (GM-CSF)-based autologous tumor vaccines.

Determine, preliminarily, the biologic activity and efficacy of this drug in these patients.

OUTLINE: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 3 months in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 48 patients (12 per disease type) will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:

Ovarian epithelial cancer

Persistent or recurrent disease after primary surgery and chemotherapy

Melanoma

Stage IV disease

Acute myeloid leukemia (AML) meeting 1 of the following criteria:

Second relapse

First relapse with no option for bone marrow transplantation

Ineligible for immunosuppressive chemotherapy due to age or comorbid disease

Myelodysplastic syndromes (MDS)

Non-small cell lung cancer

Incurable by standard surgery, chemotherapy, and/or radiotherapy

Disease previously treated with sargramostim (GM-CSF)-based vaccine therapy using lethally irradiated autologous tumor cells

No standard curative treatment exists

No immediate palliative therapy required

Measurable disease

No CNS metastases unless previously treated and stable for at least 3 months

PATIENT CHARACTERISTICS: Age:

Over 18

Performance status:

ECOG 0-2

Life expectancy:

At least 12 weeks

Hematopoietic:

WBC greater than 1,000/mm^3*

Platelet count greater than 75,000/mm^3* NOTE: * Except for patients with AML/MDS

Hepatic:

Bilirubin less than 2 times upper limit of normal (ULN)

AST and ALT less than 2 times ULN

Renal:

Creatinine less than 2 mg/dL

Immunologic

No active infection

No autoimmune disease requiring immunosuppressive treatment

No active autoimmune disease threatening vital organ function

No significant history of autoimmune disease that could be reactivated, including any of the following:

CNS (e.g., multiple sclerosis)

Eye (e.g., uveitis)

Intestine (e.g., irritable bowel disease)

Liver (e.g., hepatitis)

Kidney

Connective tissue disease (e.g., systemic lupus erythematosus, scleroderma, or polymyositis)

Heart (e.g., myocarditis)

Possible autoimmune diseases that are managed with replacement therapy are allowed (e.g., diabetes mellitus or hypothyroid)

Other:

No underlying medical condition that would preclude study participation

No concurrent medical condition requiring systemic steroids

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

See Disease Characteristics

At least 4 weeks since prior immunotherapy

No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Chemotherapy:

See Disease Characteristics

At least 4 weeks since prior chemotherapy

Endocrine therapy:

At least 4 weeks since prior hormonal therapy

At least 4 weeks since prior systemic corticosteroids

Concurrent inhaled or topical steroids allowed

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

See Disease Characteristics

At least 4 weeks since prior major surgical procedures

Other:

At least 4 weeks since other prior therapy

Recovered from prior therapy

No other concurrent investigational drugs

Phase II and Pharmacologic Study of Weekly Oral Paclitaxel Plus Cyclosporine in Patients With Advanced NonSmall-Cell Lung Cancer

PURPOSE: A phase II study was performed to assess the efficacy and toxicity of oral cyclosporine (CsA) plus paclitaxel in advanced nonsmall-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Chemotherapy-naive or previously treated patients (one regimen) with measurable disease and World Health Organization performance status  2 were eligible. Oral paclitaxel was given weekly in a dose of 90 mg/m2 bid. CsA (10 mg/kg) was given 30 minutes before each dose of oral paclitaxel.

RESULTS: Twenty-six patients with a median age of 54 years (range, 32 to 77 years) were entered onto this study. Eighteen patients (69%) had received one prior chemotherapy regimen. The most frequently recorded toxicities were as follows: National Cancer Institute common toxicity criteria grade 3 neutropenia, eight patients (31%); grade 4, six patients (23%); grade 4 febrile neutropenia, three patients (12%); grade 2/3 neurotoxicity, three patients (12%); and grade 2 nail changes, four patients (15%). The overall response rate (ORR) of the 23 assessable patients was 26% (95% confidence interval [CI], 10% to 48%). In the intention-to-treat population, the ORR was 23% (95% CI, 9% to 44%). The median time to progression was 3.5 months (95% CI, 1.2 to 3.9 months), and median overall survival was 6.0 months (95% CI, 2.3 months to not available). Pharmacokinetics revealed that the mean area under the concentration-time curve (AUC) of oral paclitaxel was 5.0 ± 2.3 µmol/L/h in week 1 and 4.6 ± 2.0 µmol/L/h in week 2, with interpatient variabilities (coefficient of variation [%CV]) of 45% and 42%, respectively. The intrapatient variability (%CV) of the AUC was 14.5%.

CONCLUSION: Oral paclitaxel plus CsA is active and safe in advanced NSCLC, including in patients previously treated with chemotherapy.

PATIENTS WITH extensive nonsmall-cell lung cancer (NSCLC) have a poor prognosis, as the disease is incurable with currently available therapy. The results of a meta-analysis revealed that cisplatin-based chemotherapy significantly increased median survival by 1 to 2 months and induced objective response rates between 15% and 30%.1-3 Several single agents such as vinorelbine,4 gemcitabine,5 irinotecan,6 and the taxanes7,8 have shown response rates between 8% and 40%, and median overall survival ranged from 6 to 11 months. The taxanes are also used in combination chemotherapy with carboplatin9 or gemcitabine.10 A recently published phase III study investigated paclitaxel as first-line treatment plus supportive care versus best supportive care in patients with advanced NSCLC and showed that the addition of paclitaxel significantly improved both time to progression (3.9 v 0.5 months) and overall survival (6.8 v 4.8 months).11 Another phase III study evaluated docetaxel 75 or 100 mg/m2 versus vinorelbine or ifosfamide as second-line treatment in patients with advanced NSCLC and has shown a significantly improved 1-year survival rate for the docetaxel arm.12 The overall response rates in both studies were low (16% and 10%, respectively), but the benefit was largely because of disease stabilization.11,12 In an attempt to increase the drug exposure over time, weekly schedules of intravenous paclitaxel were initiated and showed promising activity and manageable toxicity in several tumor types.13,14 When paclitaxel was administered as a single agent weekly for 6 weeks every 8 weeks, a dose of 150 to 175 mg/m2

intravenously can be used safely as first-line treatment and a dose of 80 mg/m2 was feasible as second-line treatment in patients with advanced NSCLC. Response rates of approximately 35% to 40% and 6%, respectively, were observed.14-16 Limited data are available thus far regarding activity and toxicity of weekly schedules as second-line treatment.

The development of an oral formulation of paclitaxel is attractive, because oral administration is convenient and practical for patients and may enable development of chronic treatment schedules resulting in sustained plasma concentrations above a pharmacologically relevant threshold level. Our preclinical studies have shown that the oral bioavailability of paclitaxel is low because of its affinity for the membrane-bound drug efflux pump P-glycoprotein (P-gp) in the gastrointestinal tract. In addition, presystemic extraction in the liver by the cytochrome P-450 system may also play an important role.17 Preclinical studies at our institute have shown that coadministration of oral cyclosporine (CsA), an efficacious inhibitor of P-gp and cytochrome P-450 3A4mediated drug metabolism, results in an approximately eight-fold increase of the systemic exposure of oral paclitaxel.18,19 The apparent bioavailability of oral paclitaxel, which did not account for the effect of CsA on systemic clearance, increased from 4% without to approximately 47% with CsA.19 Of note, no systemic exposure to the vehicle Cremophor EL was seen, which is responsible for the severe hypersensitivity reactions.19 Another study showed that P-gp inhibition by CsA was maximal at a single dose between 10 and 15 mg/kg.20 Prolongation of the time period of drug exposure of paclitaxel seemed to be more important for the activity of paclitaxel than an increase in the plasma concentration.21,22 For that reason, a bid dosing schedule of oral paclitaxel was investigated in a phase I study, and results revealed that at the dose level of 2 x 90 mg/m2, the highest systemic exposure of paclitaxel was reached with a good safety profile.23

The aim of this phase II study was to assess the activity and toxicity of the combination of oral paclitaxel and oral CsA given bid on a weekly basis in patients with advanced NSCLC who were chemotherapy-naive or previously treated with one chemotherapy line. We also determined the time to progression and overall survival of these patients. In addition, we evaluated the pharmacokinetics of this combination.

Eligibility Criteria

Patients with histologically or cytologically confirmed stage IIIB/IV NSCLC were eligible for this study. Prior taxane therapy was not allowed. At entry, patients were required to have measurable disease according to the response evaluation criteria in solid tumors (RECIST).24 They had to have adequate hematologic, renal, and hepatic functions (absolute neutrophil count [ANC] > 1.5 x 109/L, platelets > 100 x 109/L, bilirubin  1.5 times upper limit of normal, AST and/or ALT  2.0 upper limit of normal, unless liver metastases were present, then  5 times upper limit of normal, and serum creatinine  2 times upper normal limit). All patients had to have a World Health Organization performance status of  2. Exclusion criteria were concomitant use of known P-gp inhibitors and chronic use of H2-receptor antagonists or proton pump inhibitors; known history of cerebral or leptomeningeal metastases or neurologic disease; history of prior malignancy except completely excised carcinoma in situ of the cervix or nonmelanoma skin cancer; bowel obstruction or motility disorders that may influence the absorption of drugs; concurrent treatment with other experimental drugs; allergy to CsA; concomitant medication that has been reported to increase the metabolism of CsA; unresolved toxicities of previous treatment ( grade 2); intercurrent disease (active infections); and serious heart disease. The study protocol was approved by the medical ethics committees of all participating institutes, and all patients gave written informed consent.

Treatment Plan

On day 1 of each week, oral paclitaxel (Paxoral; IVAX Research, Inc, Miami, FL) was dosed bid (90 mg/m2) with at least 7 but not more than 12 hours between doses. CsA in a dose of 10 mg/kg was given 30 minutes before each dose of oral paclitaxel. CsA was supplied as capsules of 50 mg and 100 mg. Oral paclitaxel was supplied as a solution in a bottle. The solution contained paclitaxel 12 mg/mL. The pharmacist used a syringe to deliver the appropriate number of milliliters of the oral paclitaxel solution into a plastic cup for dispensing as a drinking solution. Oral paclitaxel was added to at least 50 mL of tap water or juice (not grapefruit) into the plastic cup and was shaken gently for about 1 minute and had to be ingested within 2 hours of preparation. The treatment was administered weekly until disease progression or unacceptable toxicity developed. Patients were advised to have a "light" meal consisting of one cracker and a cup of tea before intake of the drugs, and they started eating 1 hour after dosing. No antiallergic (dexamethasone, clemastine, and ranitidine) premedications were taken, because our previous phase I studies had revealed that this can be omitted.19,25 Oral granisetron in a dose of 1 mg was given 1 hour before intake of the chemotherapy to prevent nausea and vomiting.

Evaluation of Response and Toxicity

Hematology and blood chemistries were checked before treatment and subsequently weekly. All toxicities were graded according to the National Cancer Institute common toxicity criteria.26 All patients who received at least one weekly cycle of therapy were assessable for toxicity. Two dose reductions were allowed, first to 70 mg/m2 (bid) and then to 55 mg/m2 (bid), and patients who required further dose reductions were withdrawn from the study. Dose reduction of one dose level was mandated for patients who experienced common toxicity criteria grade 3 or 4 nonhematologic toxicity (except alopecia), or hematologic toxicity consisting of ANC less than 0.5 x 109/L, or neutropenic fever or thrombocytopenia less than 25 x 109/L. For patients who required dose reductions, the dosage was not re-escalated in subsequent cycles. The CsA dose of 10 mg/kg remained constant despite dose reductions. Treatment was postponed until recovery of thrombocytes more than 100 x 109/L and ANC more than 1.5 x 109/L. When treatment delay was more than 2 weeks because of hematologic toxicity, the patient was treated at the next lower dose level. Standard clinical measurements and radiologic examination were used to ensure bidimensionally measurable disease according to the RECIST criteria24 for response evaluation. Radiologic responses were confirmed by independent review. Patients who completed eight weekly cycles were considered assessable for response. The primary end point of the study was the response rate. We also determined the duration of response as the number of days between the onset of response and the date of last progression-free evaluation. For patients whose disease had not progressed, the date of last progression-free evaluation was censored. In addition, we determined the time to progression as the number of days between the date of first treatment and the date of progression or death. Survival was defined as the number of days from the date of the first dose to the date of death.

Sample Collection and Analysis

Pharmacokinetic monitoring was performed in every patient during week 1 and week 2. For paclitaxel, blood samples of 5 mL each were collected in heparinized tubes before dosing, and at 30 and 60 minutes and 2, 3, 4, 6, 7, 7.5, 8, 10, 12, 24, and 30 hours after ingestion of oral paclitaxel. For the centers outside the Netherlands, blood samples of 5 mL each were collected before dosing, and 1, 3, and 4 hours after paclitaxel intake. Blood samples were centrifuged, and plasma was separated and stored at -20°C until analysis. Paclitaxel concentrations in plasma were determined using a validated high-performance liquid chromatography assay.27 For CsA monitoring, only blood sampling was performed in the patients at the Dutch hospital at the same sampling times as for paclitaxel. Whole blood samples were stored at 4°C and analyzed within 1 week using a fluorescence polarization immunoassay (FPIA; Abbott Laboratories, Amstelveen, the Netherlands).28

Statistical Analysis

Patients were accrued according to a two-stage study design30 aiming at 25 eligible patients. Analyses of response rate and time to progression and overall survival were performed on all assessable patients. The response rate was also analyzed on the total population on an intention-to-treat basis. Confidence intervals were calculated using binomial confidence intervals.

The time to progression and overall survival curves were estimated using the Kaplan-Meier method. We calculated the interpatient variability (coefficient of variation [%CV]) in the paclitaxel AUC by dividing the SD by the mean measured values and multiplying by 100. The intrapatient variability (%CV) in the AUC was defined as the AUC value in week 1 minus the AUC value in week 2 divided by the AUC value in week 1 and multiplied by 100. All the individual values were summed and divided by the number of patients.

The results of this phase II study performed in patients with advanced NSCLC treated with oral paclitaxel in combination with CsA are encouraging and show an ORR of 26% in 23 assessable patients (intention-to-treat, 23%). This is higher in comparison with other drugs used in a single-agent setting (eg, irinotecan, gemcitabine, and vinorelbine).6,31,32 Data from 10 phase II studies in which patients with advanced NSCLC were treated with paclitaxel intravenously every 3 weeks as first-line therapy or as second-line therapy have shown an ORR of 26%.33 Only limited data are available for the activity of weekly schedules of paclitaxel in NSCLC. In general, the response rates of weekly schedules14,15 are at least comparable to the 3-weekly schedules,34-37 but responses of weekly schedules in the second-line treatment have been disappointing until now.16 It is noteworthy in our study that partial responses during paclitaxel treatment were observed in five pretreated patients with stage IIIB/IV disease. The median time to progression of 3.5 months and median overall survival of 6.0 months are in accordance with previously published studies.11,37

In general, the safety profile of this bid weekly regimen is good. In the current study, grade 3 and 4 neutropenia was the most prevalent hematologic toxicity (54%), and the incidence was comparable with the standard 3-weekly intravenous schedule.34,36,37 Neurotoxicity was reported in 31% of the patients, only one of whom experienced grade 3 neurotoxicity. The occurrence of the neurotoxicity was lower compared with the standard 3-weekly schedule.36,37 The lower peak plasma concentrations after bid dosing of oral paclitaxel might explain the reduced severity of the neurotoxicity. Lower severity of neurotoxicity was also observed in patients with ovarian cancer who received a 24-hour infusion compared with a 3-hour infusion of paclitaxel.38

The schedule used in this study allows greater dose-intensity than would be achieved with the standard 3-weekly intravenous schedule, and this may result in higher efficacy. The median dose-intensity after oral administration of paclitaxel was 172 mg/m2/wk. The apparent bioavailability of oral paclitaxel when coadministered with CsA increased to approximately 47%, when not taking into account the effect of CsA on clearance.19 This may be compared with an average dose-intensity of 80 mg/m2/wk (40 mg/m2/wk bid) when paclitaxel would be administered intravenously. Direct comparison of pharmacokinetic values and doses for oral versus intravenous paclitaxel must be made with great caution because Cremophor EL is responsible for the nonlinear pharmacokinetic behavior of intravenous paclitaxel.25 Because half of the patients experienced treatment delay, treatment with a slightly lower dose might be an alternative in future phase III studies.

Pharmacokinetics revealed that the mean AUC of oral paclitaxel administered weekly (bid) was 5.0 ± 2.3 µmol/L/h in week 1 and 4.6 ± 2.0 µmol/L/h in week 2. These data indicate good reproducibility of pharmacokinetic parameters of orally administered paclitaxel. The interpatient variability of the AUC after oral administration of paclitaxel was moderate and higher comparing the 3-weekly schedule. We demonstrated an interpatient variability of 45% and 42% in week 1 and week 2, respectively, and this was higher in comparison with intravenous data that showed values of 16% and 22%, respectively.39,40 The intrapatient variability (%CV) of the AUC in our study was low (14.5%) and indicates limited variation in absorption and elimination processes in every patient. Earlier data indicate a positive relationship between duration of the paclitaxel plasma concentration above a certain threshold level and pharmacologic activity.21,22 In our study, the high T more than 0.1 µmol/L and T more than 0.05 µmol/L per time period may therefore be a beneficial characteristic of this schedule.

The weekly single oral dose of CsA could have been associated renal toxicity or infections caused by immunosuppression.41 However, in this study, we did not observe any toxicity related to CsA. This can most likely be attributed to the weekly bid administration of the drug, whereas in the transplantation setting CsA is ingested on a chronic daily basis. We have also demonstrated in a clinical study that weekly administration of CsA plus docetaxel has no effect on immunologic parameters (Kruijtzer et al, manuscript submitted for publication).

The use of oral paclitaxel in combination with CsA may have significant advantages over the "classic" method of intravenous treatment. It enables treatment on an outpatient basis, which may increase the quality of life of the patients. Weekly bid treatment results in longer time periods of cytotoxic plasma levels. The disadvantages of the oral formulation of the cytotoxic drug are the possible interaction with food or comedication and unpredictable changes in uptake caused by vomiting or diarrhea. However, oral paclitaxel is not emetogenic, and mild nausea and vomiting were observed, especially 24 hours after intake of oral paclitaxel. This will not affect absorption of paclitaxel, which is maximum on average 1 to 2 hours after oral intake. Furthermore, the absence of Cremophor EL in this oral paclitaxel formulation offers substantial advantages. It circumvents the use of antiallergic medications, which are necessary to prevent hypersensitivity reactions.

In conclusion, in this small multicenter phase II study, promising activity was seen (ORR, 26%) in mostly pretreated patients with advanced NSCLC. Oral paclitaxel in combination with CsA is feasible and has a manageable toxicity profile. Exploration of the efficacy of the combination of oral paclitaxel with CsA in phase III studies in advanced NSCLC and other tumor types is of great interest and will be initiated.

p53 Peptide Vaccination to Treat Lung Cancer

This study is currently recruiting patients.

Sponsored by

National Cancer Institute (NCI)

Purpose

This study will evaluate the effect of a specially tailored vaccine to treat patients with non-small cell lung cancer. About 50 to 60 percent of patients with this type of cancer have a defective gene called p53, which produces a protein that protects their tumor from attack by the immune system. The vaccine is designed to stimulate the immune system to recognize the tumor cells and kill them.

The faulty p53 gene can cause various types of abnormalities that result in runaway growth of cancer cells. Each patient's vaccine will be custom matched to their specific p53 abnormality. After completing standard treatment--which may include chemotherapy, radiation and surgery--patients will be infused with the vaccine once a week for five weeks. Patients whose tumors respond to the treatment may receive additional vaccinations at two-month intervals for as long as they continue to benefit. In a previous small study, five out of five patients showed an immune response to p53 peptide vaccination.

Candidates for the study will be screened with a medical history, blood and urine tests and imaging studies (X rays and CT scans). A tumor sample will also be taken to see if it has a p53 abnormality suitable for this study. Study patients will undergo apheresis-a procedure to collect white blood cells needed to make their vaccine. In apheresis, blood is drawn through a needle in one arm, similar to donating blood. The blood goes through a machine that separates out some of the white cells, and the rest of the blood is returned, usually through a needle in the other arm. Patients will also have additional physical exams, blood tests, and imaging studies during the course of the study to evaluate the effects of treatment.

Condition  Treatment or Intervention Phase

Non-Small-Cell Lung Carcinoma

  Drug: Mutant p53 Peptides

 Drug: IL-4

 Drug: CD40L

 Phase II

MedlinePlus related topics:  Cancer

Study Type: Interventional

Study Design: Treatment, Safety/Efficacy

Official Title: Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients with Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy

Further Study Details:

Common human cancers, including lung cancer, have been found to be associated with mutations in dominant and recessive oncogenes, including the p53 gene. These cancers frequently produce mutant oncogenic proteins that are uniquely present and over-expressed in the patient's cancer cells, but not in their normal cells. Numerous somatic genetic abnormalities have been documented in cancer patients. The most extensively studied of these mutations is that of p53 which is present in approximately 50% of all cancers and in roughly 60% of non-small cell lung cancers. Mechanisms such as deletions, frameshifts, and point mutations are responsible for the development of a mutant product unique to the patient's tumor cells which allows for unregulated cell growth. This tumor specific mutant oncoprotein could form the basis for specific tumor targeted immunotherapy.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death among men and women in the United States, with roughly 180,000 new cases per year. Approximately one-third of NSCLC patients present with locally advanced disease (stage IIIA and IIIB). Despite the best conventional therapy, over 80% of these patients will die from their disease. In this protocol, we propose to evaluate the adjuvant treatment of stage III NSCLC patients after standard therapy with mutant p53 peptides custom synthesized to correspond to the mutation present in each patient's tumor. In our previous study, we have been able to demonstrate specific cytokine responses to mutant p53 peptides administered in the adjuvant setting in five out of five patients. We, therefore, believe that the adjuvant treatment of patients with lung cancer at very high risk of rapid relapse represents the optimal group in which to study the clinical response to vaccination.

To accomplish this, tumor samples will be analyzed for the presence of mutations in the p53 oncogene and a custom mutant peptide will be synthesized. It will then be used to immunize those patients after recovery from standard therapy in an attempt to induce cytotoxic T cells that specifically recognize and kill tumor cells expressing this mutant protein. The patients will be vaccinated with autologous dendritic cells produced in vitro and pulsed with custom-made synthetic mutant p53 peptide. These peptide pulsed dendritic cells will be administered weekly for five weeks via intravenous infusion in an effort to generate a host mediated immune response targeted exclusively against the tumor cells. We will then analyze both the patient's immune response to these peptides and their survival as endpoints of our study.

Eligibility

Genders Eligible for Study:  Both

Criteria

NOTE: all of these criteria must be confirmed within 4 weeks of initial vaccination and be confirmed prior to genetic screening for p53 mutations

INCLUSION CRITERIA:

Histologic diagnosis of non-small cell lung cancer.

AJCC stage IIIA or IIIB NSCLC except for patients with pleural effusions. Patients with significant pleural effusions are excluded from this study.

Patients must have completed or plan to undergo a form of curative-intent therapy for their lung cancer. Curative intent therapy is defined as at least two cycles of preoperative chemotherapy for resectable patients with known N2 or N3 disease or at least 55 Gy radiation with concomitant or sequential chemotherapy for patients judged to be unresectable. For patients found to have incidental N2 or N3 disease at time of surgery (disease not detected with staging evaluation prior to definitive surgery) adjuvant chemotherapy and radiation therapy are optional.

Eastern Cooperative Oncology Group PS 0-1.

Ability to give informed consent.

Adequate organ function including:

Renal: serum creatinine less than 2.5 mg/dl;

Marrow: total lymphocyte count greater than 475/mm(3), total granulocytes greater than 1000/mm(3), and platelets greater than 100,000/mm(3);

Hepatic: Serum total bilirubin less than 2.0 mg/dl, SGOT less than 3.0 x normal.

Submission of pathology specimen(s) for screening for one of the following types of p53 mutations: point mutation altering the protein sequence or a frame shift mutation with the generation of a novel sequence.

EXCLUSION CRITERIA:

HIV positivity, or history of Hepatitis C virus infection or active Hepatitis B virus infection due to their known effects on the immune response.

Significant pleural effusion defined as a pleural effusion visible on plain chest radiograph (whether or not cytology is positive for malignancy).

Pregnancy or breast feeding.

Other malignancies within five years, unless the probability of recurrence from prior malignancy is less than 5%. Patients who have had a malignant tumor in the past and have been disease free for at least five years are also eligible for this study.

A condition, psychiatric or otherwise, that would preclude consistent follow-up or compliance with any component of the study.

Myocardial infarction or significant ventricular arrhythmias within the last six months.

Any other serious medical condition that limits life expectancy to less than 2 years.

Hypercalcemia (serum calcium greater than or equal to 11.0 mg/dl (2.75 mmol) corrected for serum albumin).

Serum albumin less than 3.0 gm/dL.

Any serious ongoing infection.

An allergy to eggs will not exclude a patient from this study. However, patients with egg allergies will not undergo influenza vaccination.

Expected Total Enrollment:  120

Two Rebeccamycin Analogue Regimens in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

This study is completed.

Sponsored by

Ireland Cancer Center

National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Condition  Treatment or Intervention Phase

recurrent non-small cell lung cancer

stage IIIB non-small cell lung cancer

stage IV non-small cell lung cancer

  Drug: rebeccamycin analogue

 Procedure: chemotherapy

 Phase II

 MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer;   Respiratory Diseases

Study Type: Interventional

Study Design: Treatment

Official Title: Phase II Randomized Study of Rebeccamycin Analogue Via 1 Infusion Versus 5 Daily Infusions in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Further Study Details:

OBJECTIVES:

Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks.

Compare the response duration in patients treated with these regimens.

Compare the toxicity profiles of these two regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of two treatment arms.

Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1.

Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.

 Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

Histologically proven stage IIIB (with pleural effusions), IV, or recurrent non-small cell lung cancer with failure on 1 prior chemotherapy regimen

Measurable disease

PATIENT CHARACTERISTICS: Age:

Not specified

Performance status:

0-2

Life expectancy:

At least 12 weeks

Hematopoietic:

WBC at least 3,000/mm^3

Granulocyte count at least 1,500/mm^3

Platelet count at least 100,000/mm^3

Hemoglobin greater than 10 g/dL

Hepatic:

Bilirubin no greater than 1.5 mg/dL

AST and ALT less than 2 times normal

Renal:

Creatinine normal OR

Creatinine clearance at least 60 mL/min

Cardiovascular:

No New York Heart Association class III or IV heart disease

Other:

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

No concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

No more than 1 prior chemotherapy regimen

At least 4 weeks since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No concurrent combination antiretroviral therapy for HIV

Inhaled Cancer Therapy

BattellePharma is building an innovative franchise in the field of inhaled cancer therapy. BattellePharma believes inhaled cancer therapy is a significant market opportunity because the delivery of anti-cancer drugs to the lungs may result in several times the drug levels in lung tumors over IV chemotherapy. The higher drug levels are expected to increase tumor response rates, thereby increasing the quality and duration of life of people with lung cancer. The Company is actively developing its own patent-protected treatment technology that controls patient dose and fugitive aerosol. BattellePharma intends to develop and market these products under its own brand.

BattellePharma's lead product is Resmycin (doxorubicin HCl inhalation solution). Currently in Phase I clinical trials, the development of Resmycin will be conducted along classic oncology lines. On completion of these trials, Resmycin will be taken forward in Phase II trials in several tumors. A Phase III controlled study will be conducted in the most promising tumor type. BattellePharma believes this product has the potential to be used alongside existing intravenous therapy in a wide range of tumors with lung metastases as well as primary lung cancer.

BattellePharma continuously seeks co-development and co-marketing opportunities with partner companies for new chemical entities (NCE's) and other novel emerging cancer therapies amenable to aerosol delivery (both therapeutic and in the patient support area). Beyond these two relatively short-term goals, BattellePharma will actively use its existing Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop long-term solutions for this major unmet medical need.

Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases

This study is currently recruiting patients.

Sponsored by

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

 Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.

Condition  Treatment or Intervention Phase

lung metastases

Non-small cell lung cancer

Small Cell Lung Cancer

  Drug: doxorubicin

 Procedure: chemotherapy

 Phase I

 MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer;   Respiratory Diseases

Study Type: Interventional

Study Design: Treatment

Official Title: Phase I Study of Inhaled Doxorubicin in Patients With Primary Lung Cancer or Cancer Metastatic to the Lung

Further Study Details:

OBJECTIVES:

Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung.

Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population.

Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.

Obtain preliminary evidence of therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period.

Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery

Bronchoalveolar cell lung cancer allowed

Lung metastases from soft tissue sarcoma allowed

No leukemia or lymphoma

PATIENT CHARACTERISTICS: Age:

18 and over

Performance status:

Karnofsky 70-100%

Life expectancy:

Not specified

Hematopoietic:

WBC at least 4,000/mm^3

Platelet count at least 160,000/mm^3

Hemoglobin at least 9 g/dL

Hepatic:

Bilirubin no greater than 1.0 mg/dL

AST/ALT less than 1.5 times upper limit of normal

Renal:

Creatinine no greater than 1.2 mg/dL OR

Creatinine clearance at least 50 mL/min

Cardiovascular:

LVEF normal by MUGA scan or echocardiography

No unstable angina

No congestive heart failure

No symptomatic arrhythmias

Pulmonary:

DLCO at least 65% of normal

FVC at least 50% predicted

FEV1 at least 50% predicted

Resting oxygen saturation at least 90%

Exercise oxygen saturation at least 85%

No complete atelectasis

No asthma

Other:

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception during and for 6 months after study

No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal

No other concurrent illness that would preclude study therapy

PRIOR CONCURRENT THERAPY: Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

At least 3 weeks since prior chemotherapy and recovered

No prior bleomycin or nitrosoureas

No prior mitomycin greater than 25 mg/m^2

No prior anthracyclines greater than 450 mg/m^2

No other concurrent chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

At least 3 weeks since prior radiotherapy and recovered

No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy

Patients with only chest wall or primary breast radiation are eligible

No concurrent thoracic irradiation

No prior pneumonectomy

Other:

No daily or as necessary respiratory drugs via inhaler or nebulizer

No other concurrent experimental drugs

 

Approved Products:

Gemzar® (Gemcitabine)

Iressa (Gefitinib, ZD1839) (1181)

Taxotere® (docetaxel)

 

Pipeline:

Abraxane (ABI-007, Paclitaxel Albumin Stabilized Nanopartice Formulated) (2824)

ABT-510 (2872)

Advexin® Gene Therapy (INGN 201, Ad5CMVp53) (2837)

Aplidin (Aplidine, APL, Dehydrodidemnin B) (2976)

Aptosyn (Exisulind, Prevatac) (2237)

Atrasentan (ABT-627) (2977)

Avastin (Bevacizumab, Anti-VEGF Antibody, rhuMAb-VEGF) (1313)

BAM-002 (1775)

BEC2 (3191)

BLP25 (MUC1) Liposomal Vaccine (3105)

BMS 275291 (D2163) (1055)

Cantuzumab Mertansine (huC242-DM1, SB 408075) (1244)

CD3 (TTS CD3) (3352)

CeaVac® (2306)

CP-547,63