Surgery, 6 1/2 weeks of radiation, 9 months of tamoxifen and Carboplatin and CPT-11.

Since surgery, I've had the standard 6 and 1/2 weeks of radiation, including a clinical trial with a drug called Gadolinium Texephyrin (radiation sensitizer), one year's worth of CPT-11 chemotherapy and 240mg of Tamoxifen a day.

My most recent MRI showed a new growth on my cerebellum so I stopped CPT-11 and I have just began a new oral chemo called Temodar. My radiation oncologist is currently evaluating if I'm able to receive more radiation. If the answer is no, I will be starting Accutane in conjunction with the Temodar.

In addition to traditional treatment there are many things I do when I feel up to it. These include, lap swimming, yoga, T'ai Chi, acupuncture, Reiki, hypnotherapy, and plain old hanging out with friends and family

dinner after scotts film premire of No U Turn
at the Roxie theater

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CHEMO:
However, my doctors were enthusiastic for me to try both radiation and chemotherapy. They were especially optimistic for me to receive a fairly new and promising chemotherapy. I investigated some of the options, and found the following:

TREATMENT OPTIONS:
CONVENTIONAL: Surgery followed by radio and chemo therapies (many many sub-types are available)
LESS CONVENTIONAL: (but possibly effective. I've included just a few examples of each type.):
Immunotherapy : most are FDA approved. There is lots of work on this out of Duke, UCLA, etc.
Viral: Newcastle and Reovirus
Macrophages
Vaccines (pind-avi, neospringer, etc.)
too many others to list...
Gene Therapy: e.g. Herpes simplex thymidine kinase or the use of Cytokine-transfected xenogenic cells. These may turn-on the "Self-Destruct" portions of compromised DNA.
Signal Transduction inhibitors:
Tamoxifen (targets protein kinase C)
Iressa (an epidermal growth factor receptor inhibitor)
Anti-angiogenics (vascular formation supression)
Thalidomide (crude one?)
Celebrex, Vioxx, Avandia
Green Tea and Genistein (from soy)
Part of the treatment was the determination to educate myself and to include my family, in the search for solutions. We wrote to doctors and researchers from all over, based on information from internet chat rooms, TV programs, and magazine articles. Most responses were courteous and helpful, but without and radical new suggestions.

TEMODAR:
I began radiation as soon as my incision healed (stitches came out May 28th) and then started taking temozolomide (trade name Temodar). Some of the things we learned about Temodar (accuracy not guaranteed, please check with your physician!) were, as summarized by my brother Rob:

1. His immune system is compromised while being treated, so he will be taking both an anti viral and an antibacterial prophylactic medicine. One is daily, one is taken every Saturday and Sunday. They have no side effects and guard against a certain lung parasite (ewww) and things like cold sores and shingles, among other things. Some will be taken because his lymphocytes will be low.

2. He could get a faint rash or constipation, both of which can be treated with OTC meds. These will not cause fatigue.

3. He can't take any aspirin or NSAIDS (motrin, ibuprofen...).

4. Smoking hurts his overall health, so of course we are trying our best to get him to commit to quitting. It will not necessarily directly interfere with treatment, but seeing as how his lungs will be one area at risk for infection and even (rarely) a type of clotting, they said to at least cut down to a few cigs a day.

5. No alcohol . It interferes with metabolizing the drug and is bad for immune system.

6. Lastly, sterility is a real possibility. No one knows what the long-term fertility effects are, since nobody has taken this drug for longer than 7 years. While on the drug, birth control (especially for women) is vital, since it does effect reproductive system. I believe they know for fact that most people are sterile DURING treatment. So, he really ought to bank his sperm. I believe that the consensus is that one should assume a result of permanent sterility. I'm not sure how he feels about this, but he did agree with my suggestion (about banking it), so I didn't press the issue. I will ask the insurance company whether this would be a covered item.

7. Like a pregnant person, he has to steer clear of cats (in case he were scratched or bitten) and especially cat litter boxes. Otherwise there is a risk of getting toxoplasmosis if he's not already immune, which most people are if they have handled cats and litter (he has). It is an unpleasant but treatable infection. This is only semi-interesting because both we have cats.

8. Temadar is FDA approved for only Anaplastic Astrocytoma (which i think are Grade III tumors?), but the doc said it is covered liberally by insurance companies. Fingers crossed; will inquire tomorrow. (It was.) One last thing that the doc said: he saw the note in the file where Mark had said, proudly, that he was driving now. The other Doctor didn't have much of a response, but this one vehemently told him that he should not be driving . And then he looked at me and said "If I were you, I wouldn't ride with him if he's driving." Which was so harsh and kind of shocking, but I understand. They are concerned that he could have seizures without warning. However, Mark wants to drive and how can we stop him? It's difficult. I think he would only agree to stop if he was forced to admit that had some kind of reduced abilities, which he does not have right now."

RADIATION; SIDE EFFECTS AND RISKS:
Again, a description of the treatment and effects is from my brother Rob:
"The main side effect may be mild nausea. More on that below. The worst possible risk is brain edema. It can be dangerous, so we will watch for bad headaches or ones that don't respond to pain medications. This may be worsened or may be a heightened risk because the Temador seems to be a radiation sensitizer. Which is a good thing in all other regards.

We will watch for any numbness or problems with vision, speech or balance and notify the docs immediately if any occur.

One-half to three-quarters of the way through treatment, or even as early as week two, there will be hair loss. There will be four or five beams of radio hitting the head, so the losses will be there. Mark will just shave his head and he doesn't seem too fazed by it. Fatigue is common: Most people get it, and the extent varies greatly. Some just need naps. Other people feel like they are "walking and thinking in oatmeal".

A person can have any of these reactions up to 6 to 9 months after Radiation Therapy ends, which is surprising. The hair loss and fatigue will begin to reverse themselves anywhere from a couple weeks to a few months after RT is completed. The radiotherapists and nurses and residents and physicists will be the ones he sees the most during this. Our doctor will, though, see him at least once a week to check and discuss progress, problems, issues, blood results, etc.

After the RT, there will be one month of no treatment. Then, assuming we continue this course, Temodar (temozolomide) will be taken every five days out of 28. They will give him MRIs every 6-8 weeks. There will be weekly Blood Counts (CBCs) while on Temodar, too. This can take place at a satellite clinic closer to home.

About Temodar, our doctor said he's never seen such impressive results (actual shrinkage of tumors) as those with the radio and Temodar combination, as well as Temodar alone. The standard chemos, BCNU and CCNU, don't hold a candle to this treatment. He said that this, the radio plus Temodar, will be the standard approach to GBM within the next few years. Temodar will be taken nightly Monday through Friday..one hour after the anti-nausea drug Anzomet. The Temodar is 100mg, but I'm not positive because of course I can't read his writing on the prescription pad sheet! Nausea and vomiting would be a problem, but he assures us this drug will take care of it completely or almost entirely."

My radiation lasted six weeks, and at first it was a breeze. Halfway through, I began to lose my hair and feel weak and tired. I decided to have some fun with the loss of my hair and had it shaved into a checker board pattern that coincided with the bald spots. I figured humor might help me - and those around me - feel better.

I have received "Healing Music", and drank lots of green tea, and have visualized "Pak-Man" gobbling up cancer cells. I have had several church groups pray for me. Frequently! I do not know what works and what does not, but I know this: I did, and still do, feel better. All my hair grew back. Since radiation, which seems to have done its job of killing any remaining tumor cells, I have had regular MRIs that show no re-growth of tumor. I continue to take the Temodar five days per month to keep any tumor from recurring. I receive an MRI every eight weeks so we can see that nothing is recurring. The doctors and nurses are continually amazed that I have no symptoms, no seizures, and no lingering effects from radiation. I feel good and believe it is my will, the grace of God and my friends and family that have helped me make it this far with such unusual success. My medicine is extremely expensive, however, even with insurance, but I believe it may be saving my life. I pay only 15% of the cost, but this amounts to approximately $550.00 per month. The good news is, my prognosis of 6 to 12 months has become, as of August 2003, 15 months with no sign of cancer. They say that you dare not say it is gone for at least five years. I am looking forward to saying that then.

DISCLAIMER
No one in this family is a doctor. None of this data is guaranteed.We are just a family fighting to get through this. We hope it helps someone out there. No opinions, interpretations, descriptions of drugs, their effects or side effects is guaranteede. Please see your doctor for confirmation of any information you read above.

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Two craniotomies (brain surgeries), six weeks radiation followed by two week boost, Tamoxifen, Accutane, multi-vitamin and mineral therapy, physical and occupational therapy, hyperbaric treatments, CPT-11, Temodar, Neurontin and Tegretol.

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David was diagnosed with a GBM IV in July of 1996. He had emergency surgery July 3 to remove a baseball-sized tumor. The surgery was extremely successful.

After a couple weeks had gone by and we started researching GBM, we realized that we had no time to sit around and wait. We saw a regular medical oncologist, as referred to us by the surgeon. he gave us little hope. He offered us a clinical trial using chemos that had not really shown much success in treating GBM ? and suggested that we contact Johns Hopkins. We Fed-Ex'd his latest MRI's to a neuro-oncologist at Hopkins and he did not get back to us.

We became increasingly frustrated and scared so we took david's treatment into our own hands and started cold-calling contact persons for various clinical (experimental) trials across the nation. The second call was to Tracy Kerby at Duke. She talked to david for an hour and was excited that he would most likely meet the requirements for a new trial with a new, promising chemotherapy. Dr. Friedman called us that Friday night at 10:00. He said that david was too young to die (30) and that he wanted to try to save his life. We collected his scans, miscroscopic slides, and embedded paraffin slabs from the biopsy and drove to Duke that next Monday. He saw us immediately. David's scans showed a lentil-sized piece of tumor that remained -- which was necessary to measure the effectiveness of the drug. By Thursday of that week w were coming home with the first round of pills for the Temozolomide trial.

After just one month (he tookthe pills every night for five nights, then had three weeks off) the tumor was gone!! He did three more trials of the temozolomide. However, just before he was preparing to begin 3-D planning (very very important!!) for conformed field radiation, they discovered a second (OLD!!) tumor that had been evading scans (because it was low-grade -- most likely the mother of the GBM tumor that had been removed).

At Thanksgiving of 1996 he had a second craniotomy to remove a second 5 cm tumor and to have a port installed into the tumor bed. Just before Christmas he began the six weeks of radiation. In March of 1997 his scans were still clear. Henry then suggested that david have the monoclonal antibody procedure done, for which the port had been installed. Monoclonal antibodies are mouse antibodies which are piggy-backed by radioactivity. The solution is injected through the port straight to the tumor cavity. he was in isolation for seven days because he was radioactive. It sounds spooky, but it was painless.

Then in August a slice began to enhance on the scans. He began another chemo called CCNU which was taken by pill in one dose per six weeks. (It has a long half-life.) The CCNU did cause David's platelet count to drop considerably, but neither as lows the monoclonal antibodies did, nor enough to require a transfusion. He began taking vitamin-12 to boost bone marrow production and that seemed to help!! He found anti-nausea edication a MUST on dosage day. In October, the "slice" of enhancement was more enhanced. (The use the MRI and what's called a PET or SPECT scan to determine whether it is live tumor or dead necrosis . . . the PET has proven to be invalid in numerous cases over the past several months.) We began to be concerned. he did one more cycle of the CCNU and in December the "slice" had actually thickened. They then decided that he needed a biopsy to tell whether or not it was tumor or necrosis (dead tissue caused by radiation). He had the biopsy in January 1998 and the pathology proved it to be necrosis . . . :-)

Following the biopsy, david did two cycles of VP-16. It is an oral drug taken daily for 21 days, off 7 days. His blood counts were GREAT throughout the VP-16. During the first round, he suffered nausea and stomach problems however, during the second round,with increased anti-nausea medication, he did MUCH better!! Following the VP-16 he had an MRI and PET scan in mid-March 1998 which showed no change!

As of March 1998 he is taking Tamoxifen for an indefinite length of time. Tamoxifen is not a chemo, but a hormone therapy, generally used in treating breast cancer, but has shown promise in the treatment of brain tumors. It should not affect blood counts and is not supposed to cause nausea. so david continues to be "tumor free," or at least what appears to be tumor free (GBM is so hard to beat because it has microscopic cells which evade detection -- and they are made up of many different kinds of cancer cells -- some of which are sensitive to one chemo, but others which are not -- that's why he is taking variable courses of chemo therapy).

So . . . that's the story. Once we chose Duke, met Henry and his team, we never looked back. We trust him completely to treat david's tumor aggressively. Though Henry is in research and conducts so many trials, one thing he does which sets him apart and makes him so extraordinary is that if a patient is not responding positively to an experimental treatment, he pulls them off of that trial and tries something else. The patient's treatment is much more important to him than the research results. That's so cool!!

The Duke team can be contacted by calling (919) 684-5301. Please use our names as a reference! Someone WILL call you within 24 hours. That is their policy. Have your questions and information ready.

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Tom's three month MRI looked good, his brain was clean and the hole where they removed the tumor was empty except for a tiny line around a portion of the inside of the hole. The doctor said that it could be scar tissue, a benign bit of tumor or a regrowth of the Glioblastoma. At the six month MRI his brain was completely clean. There was no cancer at all. The doctor said that it was a miracle. In 14 years of practice he had not seen anything like it. This is what we did:

Take 1/4 cup Low Fat Cottage Cheese and mix it with 1 tablespoon Flaxseed oil and eat it twice a day.

Take Three 750 mg Shark Cartilage capsules three times a day

Take a Borage Oil and CoQ10 supplement

Drink plenty of water

Try to get light exercise, walking is best

Get some sunlight

For the first three months I also rubbed Frankincense on his head because it is supposed to have anti-tumor properties.

I searched on the Internet to see if there were other people having success with the flaxseed oil and cottage cheese. Go to www.beckwithfamily.com for some good testimonies and links. If you go to www.yahoo.com and go to groups there are a couple of groups, FLAXSEEDOIL and FLAXSEEDOIL2, and there is a good exchange of information there. I found other sites like www.curezone.com where people were having success beating their cancer through holistic means. Another good sight is www.shirleys-wellness-cafe.com After doing more research and talking to more people we added some things to our regimen after the first three-month MRI.

Graviola 5 drops 3 times a day

The AIM Garden Trio (BarleyLife, Carrots, Beets)

He started using an extract of a Brazilian fruit plant called Graviola (5 drops three times a day). We also added the AIM Garden Trio twice a day to build up Tom's health. Our whole family tries to take at least one AIM Garden Trio a day now.

Tom did not go vegetarian, but we did cut back on meat and sugar. We follow the biblical eating laws and do not eat any pork or unclean fish. It makes it harder for your body to fight cancer if you put unclean and artificial things into it. We think artificial sweetener caused Tom's cancer. He used to drink at least 2 liters a day of diet soda. Go to www.dorway.com for more info.

Please feel free to call Tom or I if you have any questions at all.

Tom and Kelly Rolland 985-223-1328 or Email kellyrolland@hotmail.com or Kelly@flaxoflife.com Tcrolland@hotmail.com

We just got Tom's 9 month MRI info at the beginning of December 2002. He is all clear no sign of cancer. He is back to work and back to normal. Praise the Lord Jesus!

Here is the info if you need to order any of the things that I've mentioned in my note.

Swanson Health Products 1-800-437-4148 or go to swansonvitamins.com I order the flaxseed oil, shark cartilage, CoQ10 and Borage Oil from them because they have the best prices I've found. You can find these things at a health food store too.

I ordered my Frankincense from Young Living essential oils, they are therapeutic grade oils, not perfume. Call 1-800-371-2928 and use customer #535072 to become a member

Aim Products Garden Trio
Call 1-800-456-2462 and use member ID 579373 to join. You will get wholesale prices with a membership. If you are not able to order the Garden Trio (Carrots, Beets, and Barley) I would suggest at least getting the BarleyLife. You can get these in a powder or caplets.

I get my Graviola from M7 or you can do a search for graviola on the Internet and you can buy it in capsule form.

Two Good Books:
FLAX OIL As a True Aid Against Arthritis, Heart Infarction, Cancer and Other Diseases, by Dr. Johanna Budwig and her Oil Protein Cookbook (I ordered mine from Amazon.com)

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Dear friends,

Recently I found an article written by one guy from Ukraine, who had Astrocytoma (which is close to Glioblastoma). He says he's totally clean now, with help of phytotheraphy (different kinds of plants). He also warns everyone that Chemo and Radiation theraphy are not useful at all. Moreover, he adds, it's very bad for health.

I know, that now it sounds a bit confusing, but I will find out more real soon.

I want to translate his article into English and we'll see what he says.

God bless you all !

Alex

P.S: My dad's fighting against GBM. He's Leo Shneyderis, 53 years old.

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Searching the net i have found a couple of options to try to cure glioblastoma multiforme. I think these options could be worthwhile exploring but as most of you are living in the States I thought you might know about such treatments. Maybe somebody of you has tried them? Maybe you have heard of these clinics? If anyone knows about it and could share info with us I would be immensely grateful.
The first one is the Maxine Dunitz Neurosurgical Institute in Los Angeles which is working on cancer vaccines against malignant brain tumors like glioblastoma http://www.cedars-sinai.edu/1043.html. Has any of you tried this?

The second option i have found is a kind of chemiotherapy which is practiced by doctor djerassi who has a studio in Philadelphia. He has tried a different chemio cocktail which has worked on several patients with Glioblastoma multiforme. http://www.gliomas.com I also hope this info can be useful for all visiting the site.

Regards,
elisabetta

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My husband, Joseph, was diagnosed 6/7/02 with a GBM. He went through a surgery to remove all visable tumor, but developed an infection (from the surgery--had to remove the temporal bone) which required IV therapy for a month. Then, of course, the 30 day conformal radiation which caused so many side effects--and worse yet---the tumor grew right through the whole process and a second surgery was done in November. This surgery was not as successful as the first as the DR opted (thankfully) to leave the portion growing deep within the motor area so that he would retain some motor control--"treat the tumor or treat the person," he always reminds us. His decision to treat the remaining tumor with a GliaSite (a potent, liquid radiation placed in a reservoir near the tumor for seven days) --placed in position during the second surgery--was a dubious choice to me since radiation clearly didn't work the first time.

Afterwards, Joseph had PT and OT and finally returned home. He was to start Temador on a Monday, but I received a phone call from a biochemist in England on the Saturday before and thankfully decided to give his treatment a try--it made so much sense to me as I am an RN with a holistic health background and understand healing differently then most medical people and this man offered a completely natural product WITH NO SIDE EFFECTS! Joseph has been taking this product since December--his MRI's showed that he was stable--which was a godsend in and of itself. Then in June--the best news came--tumor shrinkage!

How it works- the serum was developed using known research on the antitumor properties of fruits and vegetables. He extracts these molecules and the process begins. Different formulations are provided using state-of- the-art blood analysis and cell line cultures. My husband takes 6 tsp./day along with 2 liters of glass-bottled water and avoidance of all meats, corn, pickles and peppers. Otherwise, all organic foods are ingested as well as 4 cups of fresh carrot juice daily. The serum, rather than being cytotoxic like chemotherapy--killing cells--the serum causes the cells to go through differentiation, materation, then natural cell death. The process takes a little longer, but causes no side effects and WORKS! Our NS, who I didn't tell right away, is now offering others the option! Another NO at UCLA is starting to collect data to possibly bring this to a clinical tial. This is a long, difficult process--especially without the financial backing of a pharmaceutical company (this stage known as "Death Valley"). To help with costs we had a fund raiser. I am now in the process of starting a Foundation to assist others to have the option of a treatment like this. My husband's prognosis was maybe 3 months when he didn't respond to radiation. That was almost 10 months ago!

Please e-mail or write me if you want more info or you just want to talk. Try several times as I'm having difficulty with my e-mail lately: minjo@pro-usa.net

Bless You All,

Mindy Formento, RN
658 Rt. 47 North
Cape May Court House, NJ 08210

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Hello, my name is Tom and I have some information that i know you will be interested in.It is a company called MORINDA., In 1996 they brought a product to the market they called Tahitian Noni Juice.The Medical Field Praises Tahitian Noni Juice because represents a whole New Paradigm in the field of Natural Healing and Health Maintenance. It is a miracle juice in a bottle, well that is what some of the medical field is saying.Ralph Heinicke,PhD. Anne Hirazumi PhD. Dr. Ronald Edwards wrote (Tahitian Noni is to the 21st, century what antibiotics were to 20th century-but better-) and the list goes on.

A simple plant from French Polynesia was introduced by a friend to two well-known food scientists, Stephen Story and John Wadsworth in 1993. This Plant was destined to become The Most Unique and Important Natural Health Discovery in Decades.

Morinda is decicated to enabling everyone, everywhere to have acess to TAHITIAN NONI JUICE,

This is a Tremendous Opportunity that will help the the Financial Health and Wealth of Thousands, eventually millions, derives its power from the product.

This truly unique, benefical, and exclusive product will break through the clutter and become the industry standard for decades to come.

Tahitian Noni Juice has been used for thousands of years by the French Polynesian People to help a wide varitey of conditions,

CANCER, IMMUNE SYSTEM FAILURE, ARTHRITIS, DIABETES, WEIGHT LOSS, HIGH BLOOD PRESSURE, FIBROMYALGIA, CHRONIC FATIGUE SYNDROME, ASTHMA, STRESS, ALLERGIES, ADHA, COLDS, FLU, FEVER.

Here are two web sities that they can look at. www.tahitiannoni.com/realtreasure

and one that is Testimonials
www.noni-is-good-for-you.com

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Did you know that there is a chemical that clinical evidence suggests may be useful in the fight against the ravages of cancer? Cancer cells need glucose. A chemical known as HYDRAZINE SULFATE has been demonstrated to interrupt the glucose "feeding frenzy" characteristic of growing cancer cells. This feeding frenzy and its related metabolic disturbances in many people with cancer can cause a terrible debilitation called CACHEXIA.

Hydrazine Sulfate Hydrazine sulfate, a simple, off-the-shelf chemical, dramatically reverses cachexia (ka-KEK-si-a), the wasting-away process that kills two thirds of all cancer patients. This inexpensive drug, with little or no side effects, also has a clinically documented anti-tumor action. It causes malignant tumors to stop growing, to reduce in size, and, in some cases, to disappear. A growing number of cancer patients diagnosed as terminal have experienced tumor stabilization and remission through hydrazine sulfate therapy. About half of all patients who take hydrazine sulfate experience weight gain, restored appetite, extended survival time, and a significant reduction in pain and suffering. Many patients report an increase in vigor and strength and the disappearance of symptoms of the disease, along with feelings of well-being and optimism. While hydrazine sulfate may not be a sure-fire cancer cure, large-scale clinical trials suggest that it effects every type of tumor at every stage. It can be administered either alone or in combination with cytotoxic chemotherapy or radiation to make the cancer more vulnerable to these standard forms of treatment.

Research on the effects of HYDRAZINE SULFATE administered on carefully structured doses has shown it
to be beneficial to many cancer patients. It can be used either as an adjunct to chemotherapy or
radiation therapy, or alone. Careful analysis of the evidence seems to suggest it can be an excellent aid
against debilitation in weight loss, loss of appetite, pain and the subjective malaise or psychological
depression so often a part of cancer and its treatments. Not only that. Read for yourself the clinical
evidence and you will find that in some instances HYDRAZINE SULFATE reportedly, has inhibited tumor
growth!

Potential side effects include:

dizziness
drowsiness
nausea
mild sensations of itching of the skin.

As with an adverse reaction to any substance, your judgement must be relied upon to discontinue use and consult with your physician immediately. This should not be tried without the approval and supervision of your physician to begin with.

Possible beneficial effects include:

a reduction of pain, suffering and the wasting-away condition (cachexia)
a stabilization of symptoms and tumor growth
an improvement in appetite and weight gain
an enhancement in attitude and strength, and,
in some cases, a disappearance of symptoms and remission of the cancer.

In the proper dosages, treatment with HYDRAZINE SULFATE has accompanied dramatic results!

HYDRAZINE SULPHATE IN CANCER TREATMENT
(From the National Cancer Institute)

CANCER FACTS:National Cancer Institute / National Institute of Health

• It is estimated that half of all cancer patients experience cachexia, the rapid loss of a large amount of weight along with fatigue, weakness, and loss of appetite. Cachexia is a serious problem among many patients who have advanced cancer. Researchers are looking for ways to provide supportive care to cancer patients with cachexia.

• Scientists are studying the biological reasons for cachexia. They have found that many patients with cachexia metabolize food in abnormal ways. One problem is the abnormal metabolism of sugars and starch, which are a major source of energy from food. Normally, the body converts these carbohydrates to glucose, the simple sugar that can then be used by cells for energy. However, if glucose is not metabolized properly, the body will break down fat and other tissue, such as muscle, for energy. As a result, abnormal carbohydrate metabolism can lead to weight loss and weakness.

• Hydrazine sulfate is a chemical that interrupts abnormal glucose metabolism. Some studies have suggested that use of this drug helps improve patients' appetite and increase their weight. A study of hydrazine sulfate was conducted at Harbor-UCLA Medical Center in Torrance, California. This small study involved 65 cancer patients and showed improved survival in those patients who were in good condition.

• Based on these findings, the National Cancer Institute sponsored three randomized studies involving a total of more than 600 patients who had nonsmall cell lung cancer or advanced colorectal cancer. The patients were randomized to receive either hydrazine sulfate or a placebo. Researchers compared the treatment and placebo groups to determine whether hydrazine sulfate was effective in improving survival, reducing weight loss, and improving quality of life. None of the studies showed any significant benefit (in terms of survival, weight loss, or quality of life) to treatment with hydrazine sulfate.

• At this time, hydrazine sulfate is not approved for use in supportive care for cancer patients in the United States. It cannot be routinely prescribed by physicians.

• Supportive care for patients coping with the side effects of cancer and its treatment is an important part of good medical care. Researchers continue to look for ways to control weight loss in cancer patients. Drugs under study at this time include megestrol acetate, fluoxymesterone, and dexamethasone.

• Results of the three studies of hydrazine sulfate supported by the National Cancer Institute are published in the Journal of Clinical Oncology, Vol. 12, June 1994, pp. 1113-1129. The articles are:

"Cisplatin, Vinblastine, and Hydrazine Sulfate in Advanced, Non-Small-Cell Lung Cancer: A Randomized Placebo-Controlled, Double-Blind Phase III Study of the Cancer and Leukemia Group B" by Michael P. Kosty et al.

"Randomized Placebo-Controlled Evaluation of Hydrazine Sulfate in Patients With Advanced Colorectal Cancer" by Charles L. Loprinzi et al.

"Placebo-Controlled Trial of Hydrazine Sulfate in Patients With Newly Diagnosed Non-Small-Cell Lung Cancer" by Charles L. Loprinzi et al.

The Cancer Information Service (CIS), a program of the National Cancer Institute, is a nationwide telephone service for cancer patients and their families, the public, and health care professionals. CIS information specialists have extensive training inproviding up-to-date and understandable information about cancer. They can answer questions in English and Spanish and can send free printed material. In addition, CIS offices serve specific geographic areas and have information about cancer-related services and resources in their region.

THE REAL STORY

Hydrazine Sulfate, a simple, off-the-shelf chemical, dramatically reverses cachexia (ka-KEK-si-a), the wasting-away process that kills two thirds of all cancer patients. This inexpensive drug, with little or no side effects, also has a clinically documented antitumor action. It causes malignant tumors to stop growing, to reduce in size, and, in some cases, to disappear. A growing number of cancer patients diagnosed as terminal have experienced tumor stabilization and remission through hydrazine sulfate therapy. About half of all patients who take hydrazine sulfate experience weight gain, restored appetite, extended survival time, and a significant reduction in pain and suffering. Many patients report an increase in vigor and strength and the disappearance of symptoms of the disease, along with feelings of well-being and optimism. While hydrazine sulfate may not be a sure-fire cancer cure, large-scale clinical trials suggest that it effects every type of tumor at every stage. It can be administered either alone or in combination with cytotoxic chemotherapy or radiation to make the cancer more vulnerable to these standard forms of treatment.

Hydrazine Sulfate is now undergoing Phase III trials sponsored by the National Cancer Institute. It is available to patients as a "compassionate IND (Investigational New Drug)," a designation conferred by the Food and Drug Administration on a case by case basis, so it is no longer, strictly speaking, an "unconventional therapy." Yet even though hundreds of patients across the country are using the drug, it is not widely discussed or disseminated among practicing physicians and its promise remains largely untapped twenty-four years after it was first proposed as an anticancer treatment by Dr. Joseph Gold. Meanwhile, hydrazine sulfate is widely available in the Commonwealth of Independent States (formerly the Soviet Union), where researchers have followed up on Gold' s pioneering work with over ten years ofinvestigation supporting the drug's effectiveness.

"We've gone from a red lift to a yellow light, and hopefully will go to a green light," says Dr. Gold, director of the Syracuse Cancer Research Institute in Syracuse, New York, which he founded in 1966. Since his discovery in 1968 that hydrazine sulfate can prevent the wasting-away process in cancer patients and inhibit tumor growth, Gold has waged courageous uphill battle to win acceptance for his nontoxic chemotherapy by the medical establishment.

The American Cancer Society put hydrazine sulfate on its Unproven Methods blacklist in 1976. It condemned and stigmatized the drug following a clinical trial on twenty-nine patients at Memorial Sloan-Kettering Cancer Center in New York. But it is now widely acknowledged that the Sloan Kettering tests were botched.

When Dr. Gold made an unannounced visit to the hospital in 1974, he discovered, to his horror, that "many patients in the study were either being underdosed or overdosed. Some people who were beginning to show anticachexia response were suddenly being given 90 to 100 milligrams at one time. All this was in clear violation of the drug protocols and of our joint agreements," said Gold. The study's protocol called for patients to receive 60 milligrams once a day for the first three days, twice a day for the next three days, and three times a day for the following six weeks. Therefore, some patients were getting a 67 percent overdose.

In a letter of protest to Sloan Kettering, Gold pointed out that some patients were receiving a massive, single dose of approximately 120 to 190 milligrams a day (instead of the usual two or three 60 milligram doses), "which quickly wiped out whatever good response they were beginning to show." The study was so poorly executed that it could never be published today, he maintains.

Nevertheless, the damage was done. The ACS's blacklisting of hydrazine sulfate caused Gold's funding to dry up and scared away other researchers from following up on his early papers.

But Gold refused to give up. In 1975, he did a study of the drug's effects on eighty-four advanced cancer patients. A total of 70 percent of them experienced weight gain (or the cessation of weight loss) and reduced pain. Only 17 percent showed tumor improvements. Meanwhile, Russian scientists at Leningrad's Petrov Research Institute were getting impressive results. In one study of forty-eight terminal cancer patients treated with hydrazine sulfate, 35 percent had tumor stabilization or regression and 59 percent showed "subjective response" (ability to function normally, complete disappearance or marked reduction of pain, and so forth).

As a result of these and other favorable studies, the American Cancer Society announced in 1979 that it was removing hydrazine sulfate from its official blacklist. Only four other "unproven methods" that were once stigmatized on the ACS list as "quackery" have been removed from it. However, the ACS included hydrazine sulfate in the 1979 edition of the Unproven Methods list, and that edition continued to be circulated until 1982. Hydrazine sulfate was finally removed from the list the next time the list was revised, in July 1982.

Tim Hansen, now in his early twenties, of Minneapolis, Kansas, is one person grateful for the existence of hydrazine sulfate therapy. In August 1984, when he was eleven years old, Tim was diagnosed with three inoperable malignant tumors that were growing quickly in his brain. He was placed on radiation therapy, but his health steadily deteriorated until, by early 1985, his weight had dropped to fifty-five pounds. "The radiation harmed his mental functioning, and in January 1985 the surgeon told me that Tim had one week to live," says Gloria Hansen, Tim's mother.

In February, after reading a short item about hydrazine sulfate in Mc Call's, Gloria and her husband, Ray, got in touch with Dr. Gold, and Tim was put on hydrazine sulfate therapy by his physicians in Kansas. By August, his weight was up to seventy-five pounds. By early 1987, two of Tim's tumors had completely vanished. In January 1991, a computerized axial tomograph (CAT scan) revealed further shrinkage of the remaining tumor, located in the base of the brain. Dr. Gold plans to keep Tim on the hydrazine sulfate protocol until the tumor is completely gone.

Tim graduated from high school in 1990 and is now studying electronics at a trade school, getting A's and B's.

Dr. Gold first stumbled upon hydrazine sulfate's anticancer properties during his methodical quest for a specific type of therapy. Cancer has two principal devastating effects on the body. One is the invasion of the tumor into the vital organs, with the destruction of the organs' functions&emdash;the most common cause of cancer death in the public's mind. In reality, however, this accounts for only about 23 percent of the country's half-million annual cancer deaths.

The other devastating effect of cancer is cachexia, the terrible wasting away of the body, with its attendant weight loss and debilitation. In cancer, as in AIDS, patients succumb to the accompanying illnesses, which they would otherwise survive if not for the wasting syndrome.

"In a sense, nobody ever dies of cancer," notes Dr. Harold Dvorak, chief of pathology at Beth Israel Hospital in Boston. "They die of something else - pneumonia, failure of one or another organs. Cachexia accelerates that process of infection and the building-up of metabolic poisons. It causes death a lot faster than the tumor would, were it not for the cachexia."

Halting the wasting syndrome instead of directly attacking the cancer cells with poison was Dr. Gold's plan of attack. As he explains, "Each of these processes [the tumor invasion of vital organs and cachexia] has its own metabolic machinery, each is amenable to its own therapy, and each is to some degree functionally interdependent on the other. In the interest of treating the totality of malignant disease, each of these processes warrants intervention. Such an approach, dealing with both major underpinnings of the cancerous process - mitogenic and metabolic - affords the greatest promise for eliciting long-term, symptom-free survival and the potential for disease eradication."

WHAT CAUSES CACHEXIA?
Cancer cells gobble up sugar ten to fifteen times more than normal cells do. The sugar consumed by the cancer cells is generated mainly from the liver, which converts lactic acid into glucose. (Normal cells are far more efficient users of glucose, which they derive from the food we eat, not from lactic acid.) When cancer cells use sugar (glucose) as fuel, they only partially metabolize it. Lactic acid&emdash;the waste product of this incomplete combustion&emdash; spills into the blood and is taken up by the liver. The liver then recycles the lactic acid (and other breakdown products) back into glucose, and the sugar is consumed in ever-increasing amounts by voracious cancer cells. The result is a vicious cycle, what Dr. Gold calls a "sick relationship" between the liver and the cancer. The patient's healthy cells starve while the cancer cells grow vigorously. Some healthy cells even dissolve to feed the growing tumor.

To break this sick relationship, Gold reasoned, all he needed was to find a safe, nontoxic drug that inhibits gluconeogenesis ( the liver's recycling of lactic acid back into glucose). In 1968, he outlined his theory in an article published in Oncology. "The silence was deafening, he recalls. A year later, by a remarkable coincidence, Gold heard biochemist Paul Ray deliver a paper explaining that hydrazine sulfate could shut down the enzyme necessary for the production of glucose from lactic acid. Gold had chanced upon an eminently logical way of starving cancer. He immediately tested hydrazine sulfate on mice and found that in accord with his theory, the drug inhibited both gluconeogenesis and tumor growth.

Over the years, many dramatic remissions in patients on hydrazine sulfate therapy have been reported.

In one case, a sixty-two-year-old woman with widely disseminated cancer of the cervix, in a very debilitated condition, was put on the drug. After one week, a secondary tumor the size of an orange had completely disappeared, much to the amazement of the woman's doctors, and neck nodes had become markedly smaller. After three weeks on the therapy, the patient had gained weight and was active and in good spirits. The woman was discharged from the hospital a short time later.

In 1987, Erna Kamen, a sixty-three-year-old lung cancer patient, was administered hydrazine sulfate after her discharge from a Sarasota, Florida, hospital. "Basically, my mother was sent home to die," says Jeff Kamen, an Emmy-winning television reporter. "She'd lost a significant amount of weight by then, and she had no appetite and virtually no will to do anything." A doctor had told Jeff's father, Ira Kamen, that hydrazine sulfate offered at least "a shot in the dark." So one Monday in August 1987, a home nurse gave Mrs. Kamen one hydrazine sulfate pill shortly before serving lunch. "On Tuesday morning," recalls Jeff, "there was a commotion in the house. My mother had risen from her bed like the phoenix rising from the ashes. She was demanding that the nurse bring her downstairs so that she could have breakfast with me.... When people you love get into this kind of facedown with death, you're just incredibly grateful for each moment."

As Jeff describes his mother's recovery, "her searing pain was gone; her appetite returned at a gallop." Within three weeks, her racking cough had vanished and she could walk unaided. "In the months before her death, she went on television with me to tell the nation about hydrazine sulfate. The National Cancer Institute stopped trashing hydrazine sulfate and began referring inquiries to the UCLA Medical School team whose work had validated the effectiveness of the drug long before Erna Kamen began taking it." Jeff attributes his mother's death months later to her being "mistakenly taken off hydrazine sulfate and subjected to an unproven experimental substance."

With cancer patients, hydrazine sulfate is usually administered orally in 60-milligram capsules or tablets, approximately one to two hours before meals. It is given at first once a day for several days, then twice a day, then three or four times daily, depending on the patient's response and the physician's judgment. On such a regimen, many terminal and semiterminal patients have derived considerable benefit, although patients in the early stages of the disease derive the most benefit from the treatment.

Approximately half of the patients to whom the drug is properly administered in the early stages of the disease show an almost immediate weight gain and reversal of symptoms; in some instances, the tumor eventually disappears. The common types of cancer most frequently reported to benefit from hydrazine sulfate therapy are:

recto-colon cancer
ovarian cancer
prostatic cancer
lung (bronchogenic) cancer
Hodgkin's disease and other lymphomas
thyroid cancer
melanoma
and breast cancer

.Some less common types of cancer also benefit.

"Whether hydrazine sulfate should be used in conjunction with other agents seems to be dependent on whether these agents are doing the patient any demonstrable good," according to Dr. Gold. "In the instances in which these agents have been doing good, hydrazine sulfate should be used in conjunction with them. However - and especially with those cases on toxic drugs - in instances in which the drugs have been doing no evident good, it is probably best to withdraw such drugs and use hydrazine sulfate alone." Many alternative therapists disagree. They see hydrazine sulfate as mainly an adjunctive treatment, albeit a potentially powerful one.

Critics have made much of the fact that hydrazine sulfate, a common industrial chemical, is found in such products as rocket fuel, insecticides, and rust-prevention agents. For medical purposes, however, the salt is refined, purified, and used in reagent-equivalent grades. Given to patients in minuscule amounts, it occasionally produces mild, transient side effects such as nausea, dizziness, itching of the skin, drowsiness, and euphoria, but such side effects are minimal, especially when compared with the devastating effects of standard chemotherapy.

A very small percentage of patients undergoing long-term, high dosage hydrazine sulfate therapy experience pain or temporary numbness in their extremities, but this condition is quickly controlled by reducing the dosage and administering vitamin B6. In no known cases has hydrazine sulfate depressed or destroyed white blood cells or bone marrow, as conventional chemotherapy often does. In general, toxicity has been exceedingly low or nil.

The most recent study of this drug, however, concluded that hydrazine sulfate appears not to be beneficial and may even have neurological side effects. This study involved a nationwide, twenty-month trial with 291 advanced non-small-cell lung cancer patients, all of whom received chemotherapy. In the double-blind phase, half were given hydrazine sulfate, while the other half received a placebo. Patients receiving hydrazine sulfate had a median survival of 7.62 months, while the comparable figure for those on placebo was 7.5 months. Hydrazine sulfate had no effect on cancer cachexia, according to Michael Kosty, M.D., an oncologist with Scripps Clinic and Research Foundation in La Jolla, California, who was the study's principal investigator, nor were differences noted between the two groups in anorexia or weight gain. Furthermore, the placebo group rated their quality of life higher than did those patients taking hydrazine sulfate, and some hydrazine sulfate patients experienced loss of sensation and motor function. "Therefore, the best we can say about this drug is that it has no effect and may even be deleterious," Dr. Kosty was quoted as saying in a summer 1992 issue of ASCO Highlights, a publication of the American Society of Clinical Oncology.

Dr. Rowan Chlebowski, director of a UCLA research project on hydrazine sulfate, conservatively estimates that the drug could benefit about half a million cancer patients each year in the United States alone. His team has conducted many clinical studies of hydrazine over two decades. Dr. Chlebowski says that the drug's indirect mode of action against tumors is problematic to more cautious investigators. "We found that hydrazine sulfate was an anticachexia agent that indirectly induced antitumor responses without much toxicity. Its action is not directed at cancer cells yet it may profoundly affect them."

Dr. Chlebowski and his colleagues at the Harbor-UCLA Medical Center in Torrance, California, recently found evidence that hydrazine sulfate added to conventional chemotherapy improves the nutritional status and prolongs the life of patients with non-small-cell lung cancer, especially deadly forms of the disease. In the January 1990 issue of the prestigious Journal of Clinical Oncology, he reports that earlier-stage patients have a median survival time of at least 328 days, compared to 209 days for the placebo group. There is no curative therapy for this type of lung cancer, so the results, if confirmed, seem promising.

The wasting syndrome seen in cancer patients is also a prime risk factor for AIDS patients with Kaposi's sarcoma. There is evidence that hydrazine sulfates capacity to stop cachexia may save many AIDS patients. Currently, Dr. Chlebowski is planning a study to test hydrazine sulfate as an anticachexia agent in patients who are infected with HIV and have lost weight.

Even though hydrazine sulfate is now undergoing extensive Phase 111 trials sponsored by the National Cancer Institute, resistance to this inexpensive, nontoxic chemotherapy in orthodox medical circles persists. Dr. Vincent DeVita, former director of the NCI, told a Washington Post reporter in 1988 that he thought hydrazine was a "ho-hum idea." Dr. Gold, until recently, has been frozen out of the "war on cancer." Two articles on cachexia published in July 1990 in the prestigious Cancer Research journal fail to reference any of Gold's path-breaking work, and one even denies there is any effective treatment for the wasting-away syndrome.

Dr. Gold, who does not treat patients, says that the cost of hydrazine, at most, should be nominal - comparable to the daily cost of insulin and other supplies for diabetics. "Until a pharmaceutical company sponsors the drug through the FDA, it will not be widely in use," he predicts, adding, "However, with the new studies, drug companies have suddenly begun to take notice of this most exemplary drug."

HYDRAZINE SULPHATE AND METABOLIC INHIBITORS The metabolic inhibitor Hydrazine Sulfate might theoretically induce anabolism by blocking catabolic pathways, presumably by inhibiting the gluconeogenic enzyme phosphoenolpyrovate carboxykinase and preventing the energy requiring conversion of lactate to glucuse.

Early studies had reported no significant benefit stemming from Hydrazine Sulfate use in cancer patients. However, more recent studies have found that Hydrazine Sulfate therapy improved appetite and increased serum albumin and caloric intake in lung cancer patients. Ongoing clinical trials have been designed to further evaluate these encouraging new clinical findings in cancer patients. Whether Hydrazine Sulfate will produce a similar effect in AIDS patients is not yet known.

MAO INHIBITOR WARNING:
If you are taking a MAO Inhibitor (one of a class of drugs prescribed to counter depression, lower blood pressure, and treat infections and cancer), avoid the chemical tyramine and its precursor, tyrosine. Combining MAO inhibitors with tyramine causes the blood pressure to soar. Patients taking Hydrazine Sulfate who experience the symptoms indicating high blood pressure, should discontinue medication and contact their physician.

Tyramine-containing foods include: almonds, avocados, bananas, beef or chicken liver, beer, cheese (including cottage cheese), chocolate, coffee, fava beans, herring, meat tenderizer, peanuts, pickles, pineapple, pumpkin seeds, raisins, sausages, sesame seeds, sour cream, soy sauce, wine, yeast extracts (including brewers yeast), yogurt, and other foods. In general, avoid any high-protein food that has undergone ageing. Over-the-counter mouthwash, cold and allergy remedies should also be avoided if it has any alcohol content. Hydrazine Sulfate is a MAO Inhibitor.

IMPORTANT: MAO Inhibitors - The special diet restrictions apply only to patients with High Blood Pressure. Others may eat all these foods in moderation.

As observed in the Syracuse Cancer Research Institute, the suggested clinical dose for cancer patients is as follows: Persons 95 lbs. or less (30mg capsule):
Day 1: One (1) capsule with breakfast for three (3) days
Day 4: Increase dosage to one (1) capsule with breakfast, and one (1) capsule/tablet with lunch, for
three (3) days.
Day 7: Increase dosage to one (1) capsule with breakfast, one (1) capsule/tablet with lunch, and one
(1) capsule/tablet with dinner. This is a maintenance dose.
Persons between 95 and 121 lbs. (60mg capsule):
Day 1: One (1) capsule with breakfast for three (3) days
Day 4: Increase dosage to one (1) capsule with breakfast, and one (1) capsule with lunch. This is a
maintenance dose.
Persons over 121 lbs. (60mg capsule):
Day 1: One (1) capsule with breakfast for three (3) days
Day 4: Increase dosage to one (1) capsule with breakfast, and one (1) capsule with lunch, for three
(3) days.
Day 7: Increase dosage to one (1) capsule with breakfast, one (1) capsule with lunch, and one (1)
capsule with dinner.
Maintain this dose for six (6) weeks, followed by a two (2) week rest period. After two (2) weeks rest period, dosage may
be repeated as from day 1.

Taking a single dose of more than 60 mg. is not recommended in the clinical studies. As with any drug, overdosing in any way is greatly discouraged and potentially dangerous.

HYDRAZINE SULFATE is being tested with promising results at cancer institutes and research centers around the world. It is also being used by some HIV and AIDS patients to combat the characteristic wasting away of the body.

HYDRAZINE SULFATE's original proponent, Dr. Joseph Gold of the Syracuse Cancer Research Institute of New York has been fighting years for acceptance of this virtually side effect free, non toxic cancer therapy despite the reluctance of more rigid, conventionally entrenched, orthodox practitioners who now may be taking another look at the results in both America and abroad.

The use of tranquilizers, barbiturates and/or alcoholic beverages with hydrazine sulfate destroys the efficacy of this drug and increases patient morbidity. Pregnant and nursing mothers should consult their physician before taking any substance, including HYDRAZINE SULFATE.

HYDRAZINE SULFATE (60mg - 100 caps) $60(US) $75(CDN)

To find out more, Call Darrell L. Wolfe at
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please call us at
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Updated April 29, 2002

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