Cancer: Clinics Offering Alternative Therapies

This protocol profiles many (but not all) prominent cancer clinics staffed by individuals who are considered to be capable of piloting an alternative approach against cancer. Descriptions are detailed in the hope that patients may find physical, emotional, and geographic links with a particular clinic or natural therapy.

When describing the various complementary cancer clinics, it is not possible to endorse one treatment or physician over another. We have provided as much evidence as space allows assisting patients and their physicians in the evaluation of what approach may be suited for the individual situation.

A great deal of effort has been made to identify therapies that have some substantiation in the published scientific literature and provide the cancer patient with the opportunity to experiment with cutting edge treatment strategies. The focus of our effort has been to identify potential life-saving therapies that are not part of mainstream oncology.

The Life Extension Foundation can assume no responsibility for treatment or outcome, apart from a self-assigned duty to stay abreast of the most promising of therapies and to share the data with members. No warranties (expressed or implied) accompany the material; neither is the information intended to replace medical advice. As always, each reader is urged to consult professional help for medical problems, especially those involving cancer. All clinics are listed in alphabetical order and not in order of importance. Before choosing any alternative cancer clinic, we suggest logging on to a special website (www.lefcancer.org) to obtain updated positive or negative information about a particular clinic.

ALOE VERA, A GLYCONUTRIENT

Dr. H.R. McDaniel, M.D., an affiliate of Mannatech Inc., has spent 16 years exploring the therapeutic nature of Aloe vera. In 2000, McDaniel addressed Comprehensive Cancer Care, a conference highlighting the latest and most promising of current techniques converging upon cancer therapy. As a result of this appearance, Dr. McDaniel was invited (August 28, 2001) to present the glyconutrient principle before the Royal Society of Medicine (London, England) and the United Nations-sponsored 17th International Conference on Nutrition. The following material (excerpted from these presentations) should be viewed as part of an integrated approach to treat cancer, not as an independent therapy.

The virtues of the aloe plant (chronicled in the writings of Hippocrates) have evolved to include a strong anticancer connection (Corsi et al. 1998). It was determined that aloe juice reduced tumor mass and the frequency of metastasis in rats (Gribel et al. 1986). Aloe protected individuals with weakened immune systems against infection (Klein et al. 1988). Random scientific papers, plus scores of anecdotal reports relating to cancer regressions, spurred a group of physicians and scientists to study the nature and role of carbohydrates in biological events; a science referred to as glycobiology emerged.

The active ingredients in aloe are eight chains of mannose sugars, (glucose, galactose, mannose, fructose, xylose, N-acetylglucosamine, N-acetylgalactosamine, and N-acetylneuraminic acid). Scientists determined that the eight sugars (super carbohydrates), frequently missing in the diet, are important to intercellular communication (Reynolds et al. 1999).

Glycoproteins (on the surface of every cell) serve as signals to tell other cells who they are and what they need. If the cells do not have enough of the right sugars, they cannot make the correct glycoproteins, and the cell-to-cell messages become disrupted. Subsequently, the immune system cannot effectively wage an offensive against bacterial and viral pathogens or rapidly dividing cancer cells. The sugars of aloe ensure that internal networking (cell-to-cell communication) is swift and accurate.

Note: The reader should not confuse the natural sugars of Aloe vera with sucrose, that is, common table sugar. The sugars contained in glyconutrients are naturally occurring sugars (not sweet to the taste) that elicit no blood glucose rise or insulin rush.

A number of enzymes (endonucleases, hydrolases, esterases, and lipases) are produced from the sugars of aloe. Enzymatic reactions power up lymphocytes, white blood cells (about a trillion in number) that bear the major responsibility of immune surveillance. When white blood cells phagocytose (envelop and destroy) bacteria, virus, and cancer, enzymes produced on the mannose system optimize the cell's performance.

Aloe vera has an extraordinary antioxidant profile, with much of its activity gained by increasing reduced glutathione levels (Hu et al. 2003). Antioxidants neutralize free radicals produced as a result of aggressive cancer treatments, as well as those produced naturally through biological events. For example, as the mitochondria produce energy to fuel cellular functions, a plethora of free radicals results. A cell deprived of reduced glutathione is unprotected and subject to free-radical damage (a precursor to cancer) (Toyokuni 1998). Reduced glutathione can independently protect against free radicals or increase the efficiency of vitamin E (a lipid-soluble antioxidant), vitamin C (a water-soluble antioxidant), and superoxide dismutase (an enzyme that converts superoxide radicals into less toxic agents). Many patients may be able to complete aggressive courses of chemotherapy when aloe accompanies treatment (Nersesian et al.1990; Wang et al. 2001).

Dr. Glen Hyland, a Mayo trained oncologist, reviewed the health histories of 100 cancer patients (extracted from a three-state analysis) who used glyconutrient therapy as a part of their cancer treatment. Dr. Highland marveled at the speed at which patients receiving glyconutrients experienced a reduction in the size of squamous cell carcinomas (lung) and oat cell carcinomas (usually originating in the bronchi or lungs). Numbers of erythrocytes (red blood cells), leukocytes (white blood cells), and thrombocytes (platelets) did not diminish when glyconutrients were a part of cytotoxic therapies. Dr. Hyland commented that normal cells appeared protected and abnormal cells appeared more sensitive to treatment, when Aloe vera was a part of an integrated approach.

Various cancer patients have experienced remarkable reversals in health status after adding aloe to their protocol. It was, in fact, triumphant accounts of Aloe vera enhancing the efficacy of previously failed treatments that spurred the glyconutrient movement. From the files of Dr. McDaniel, a few case studies have been extrapolated to illustrate the value of Aloe vera as an adjunct in cancer therapy.

• A male (68 years old) presented the symptoms of obstructive urinary symptoms, elevated PSA, and more than 100 nodules of metastatic lesions in the lungs. Dreadfully ill and having failed other therapies, polymannose, a first-generation glyconutrient discovered in the early 1980s, was added to the protocol. After an additional year of conventional therapy (that included Aloe vera), the lungs were cleared of nodules, energy levels rebounded, and quality of life returned. He appears quite healthy as he approaches the 10th anniversary of being told his condition was terminal.
• A researcher, trained under a NIH cancer fellowship and hostile toward the carbohydrate/cancer theory, reluctantly entered into a trial to determine the value of glyconutrients in cancer treatment. Laboratory mice were injected with Norman's Sarcoma, a type of cancer carrying a 100% death rate; half of the test animals were also injected with 1 mg/kg of the glyconutrient polymannose. About 1 month into the trial, all control animals were dead; conversely, all animals receiving one injection of polymannose were alive, and at the 2-month interval, 40% had survived. Amazed with the results, the researcher repeated the test, but doubled the concentration of the carcinogen. The results were, nonetheless, the same. The odds improved when the therapeutic injections were increased: 52% were alive when receiving 1 injection per week, and 67% survived when the complete formula (all monosaccharides required for glycoprotein synthesis) was injected.
• A 38-year-old breast cancer patient presented with 10 lytic skeletal bone lesions and a mass appearing on the neck. The patient also had liver involvement and ascites (an intraperitoneal accumulation of water and electrolytes) making her appear 8 months pregnant. Having failed earlier courses of chemotherapy, the treatment was repeated, but this time glyconutrients were a part of the protocol. At 1 year, the ascites had cleared, and no evidence of cancer was detected. She survived approximately 7 years after being advised by her oncologist that she had less than 6 months to live.

Reports of Aloe vera being life-saving to cancer patients are not scarce. Dr. Julian Whitaker reported that a 10-year-old boy diagnosed with a rare brain tumor (a meningioma) went into total remission after drinking 8 oz of whole-leaf Aloe vera concentrate a day for 3 months. Because surgeons were unable to remove the entire tumor, its continued growth rendered an uncertain prognosis. At the time of the Whitaker report, the child was living a normal life and participating in sports but drinking Aloe vera juice every day (Whitaker 1995).

The following animal trials are included to add additional strength to human studies. Acemannan, a polysaccharide (carbohydrate) isolated from aloe rind, was administered intraperitoneally and intralesionally to 43 dogs and cats with spontaneous tumors. Twenty-six of the animals showed histopathological evidence of immunological attack, evidenced by marked necrosis or lymphocytic infiltration. Twelve animals experienced obvious clinical improvement as assessed by tumor shrinkage, tumor necrosis, and prolonged survival (Harris et al. 1991).

Feline leukemia is a disease induced by an oncornavirus infection that inevitably causes death to clinically affected cats. It has been estimated that 40% of cats are dead within 4 weeks and 70% are dead within 8 weeks of the onset of symptoms. Administering acemannan for 6 weeks intraperitoneally to clinically symptomatic cats significantly improved quality of life and survival rates: 12 weeks after initiation of treatment, 71% of treated cats were alive and in good health. This study joins a medley of others, affirming Aloe vera's worth in veterinary settings (Sheets et al. 1991).

Oral administration of Aloe vera is remarkably safe. It is, in fact, difficult to estimate lethal dose ranges via animal studies (Ikeno et al. 2002).

Suggested dosage: Begin with 2 tsp of glyconutrient powder 3 or 4 times a day. Some find they must slowly increase the dosage to achieve maximum benefits.

Mannatech Aloe vera products may be purchased at (800) 287-8373 (without an account) and at (800) 281-4469 (with an account). Complete documents relating to the material presented are available from the Fisher Institute for Medical Research, helen@fisherinstitute.org , Fax: (972) 660-1245, or Telephone: (972) 660-1733). In addition, readers may be privy to information presented before the Royal Society of Medicine and the United Nations-sponsored 17th International Conference on Nutrition by purchasing tapes of Dr. McDaniel's Comprehensive Cancer Care 2000 lecture from the Conference Recording Service Inc. or by calling (800) 647-1110.

BINDWEED (AN ANGIOGENESIS INHIBITOR)

The RECNAC team (CANCER spelled backwards) is located in Wichita, KS, at The Center for the Improvement of Human Functioning International. A breast cancer survivor of 14 years, who used the Center's approach to fight her disease, altered the name to counter the grim aura that frequently hovers over cancer. Dr. Hugh D. Riordan, RECNAC Project Director, says the key to finding successful treatments for cancer is identifying where to look and being willing to search in unusual places. Dr. Riordan emphasizes the importance of finding ways to nurture and soothe the spirit of the cancer patient as well as the body. The Center, referred to as the Bright Spot for Health, has welcomed thousands of people from all 50 states, the District of Columbia, Puerto Rico, and 40 foreign countries. A hopeful, confident clinical environment tends to assure patients and expedite recovery.

Impressive cancer research is emanating from the Midwest, more specifically Wichita and physician/researcher Hugh Riordan, M.D., and his corroborating team of scientists. The following narrative illustrates why many in the scientific community are excited about their work.

A survivor of ovarian cancer entered the clinic relaying a hopeful story concerning her recovery. Following diagnosis, the woman, concerned with orthodox therapies, independently sought an alternative treatment. The decision to look elsewhere was not difficult because the woman's mother had died 7 years earlier with the same disease and doctors felt the daughter's chances of survival equally bleak.

The woman traveled to Oklahoma where a shaman gave her a tincture of Bindweed (Convolulus arvensis) with instructions to use the substance daily. (Bindweed, a common garden weed, is a bane to farmers.) The woman testified that after using Bindweed for 1 year, her abdomen returned to a normal size. Asymptomatic, she returned to her physician, who after a battery of tests pronounced her cancer-free.

The Riordan team began assays to determine the beneficial properties of Bindweed. Its mode of operation was puzzling because it appeared ineffective at killing tumor cells and only modestly efficient at improving immune function. After nearly 4 years of searching, it was determined that Bindweed bestows its antitumor advantage by inhibiting angiogenesis, a process that restrains (tumor) blood vessel formation. A chaotic vascular system is a common property of malignant tissue. So important is the blood vessel network, tumor cells participate in their own survival by secreting cytokines that develop and sustain the vascular pipeline. Tumor growth requires an adequate supply of blood vessels; robbed of its vascular system, the tumor starves and shrinks and, in some cases, completely disappears. It was determined that Bindweed was about 100 times more effective than shark cartilage (by weight) at inhibiting angiogenesis (Meng et al. 2002).

After identifying proteoglycan molecules (PGMs) as the antitumor property in Bindweed, the chicken egg chorio-allantoic membrane model was used to determine the extent of Bindweed's antiangiogenic activity. About 200 fertilized chicken eggs were prepared to allow a working surface inside the egg. Tumor cells were added that secrete cytokines, eliciting new tumor blood vessel growth. The angiogenesis inhibiting substance was then added and the rate and degree of angiogenesis observed. Scientists concluded that proteoglycan molecules inhibited new tumor blood vessels in a dose dependent manner, that is, results were 18%, 55%, and 73% inhibition at concentrations of 50, 100, and 200 mcg, respectively (Meng et al. 2002).

PGMs were then tested in animal models. B16 melanoma, LS180 (a colon adenocarcinoma), and Lewis Lung carcinoma all showed from 70%-99.5% inhibition of growth. The RECNAC team classed Bindweed as an all-tumor inhibitor, meaning it appears equally effective in inhibiting the progression of all tumors.

The RECNAC team found that when Bindweed was used with an immune stimulant, that is, a nontoxic purified extract of the bacterial cell wall of Gram-positive bacteria and beta 1, 3-glucan, the results were even more remarkable. The combination, referred to as a Muramyl Polysaccharide-Glycan Complex (MPGC), stimulates the immune system in a fashion not unlike that observed when Bacillus Calmette-Guerin (BCG), inactivated tuberculosis germ, is used to combat cancer. The muramyl peptides are recognized by the immune system as belonging to a bacterial invader; subsequently, the immune system is activated, mustering a nonspecific attack against bacteria, viruses, fungi, and cancerous cells (Pabst et al.1999). To increase the response, the peptides are linked to mannose-rich polysaccharides, which make it easier for the macrophages to engulf the cell wall for identification and immune activation.

The macrophages are also sensitized to phosphatidylserine and muramic acid, both of which are found preferentially on tumor cells. In essence, the immune system becomes flagged by the identifiable characteristics of the cancer cells and subsequently eliminates the cancer cells.

Muramyl peptides increase tumor destroying mechanisms and up-regulate monocyte cytokine genes (IL-1 beta, IL-6, IL-8, tumor necrosis factor, and IL-12) (Allison 1997). Although IL-12 is an immune stimulator, it is one of the most potent angiogenesis inhibitors known (Morini et al. 2004;
Strasly et al. 2001).

Note: Pro-inflammatory cytokines are observed in a number of different cancers, even proving predictive of survival. This raises questions regarding safe usage of natural agents that elicit production of both pro- and anti-inflammatory cytokines.

According to Dr. C.A. Dinarello (University of Colorado), most of our knowledge regarding pro-inflammatory cytokines (such as IL-1 or TNF) is derived from experiments in which humans or animals have been injected with either a single or a combination of inflammatory cytokines (Dinarello 1997). However, in models of inflammation where several cytokines are produced, specific blockade of either IL-1 or TNF (or both) results in a reduction in the severity of inflammation. This may explain the success of agents that lift expression of many of the family of cytokines, both pro- and anti-inflammatory in nature. Please refer to the section entitled Pro-inflammatory Cytokines in the protocol on Cancer Treatment: The Critical Factors, to learn about the role of cytokines in malignancies.

In addition, MPGC results in the maturation of immature dendritic cells. This is significant because immature dendritic cells initiate the immune response by engulfing abnormal cells. After identifying the foreign antigen, dendritic cells mature to present the information to T-cells to initiate the fight. Unfortunately, cancer cells possess a survival wit, that is, they can hide from the immune system by lacking identifiable antigens on their cell surfaces; the task becomes doubly difficult as some cancers can suppress dendritic cell maturation. Please consult the Cancer Vaccines protocol to learn how dendritic cells can be trained to identify cancer cells and gear up an attack. The other component of MPGC is beta 1,3-glucan (made from fungus cell walls). Beta 1,3 D-glucan is independently able to increase the activity of macrophage, potentiating detoxification, internal hygiene, and defense against cancer cells.

EXAMPLES OF PATIENT REPORTS FROM THE CENTER:

• Pancreatic cancer: A woman presented at the clinic with a very large pancreatic mass with metastasis to the liver. During earlier surgery, a biopsy identified a poorly differentiated adenocarcinoma at the head of the pancreas. The liver was described as full of tumors, rock-hard, and palpable at the level of the umbilicus (or navel). Dr. Riordan began an IV of vitamin C and pancreatic enzymes. At the 2-month interval, although the woman was alive, the tumors showed no signs of regression. At that time, Bindweed was added to the protocol. Within 8 days, the tumor felt softer to the touch, and within a couple of weeks, the tumor shrinkage was dramatic. Simultaneously, laboratory values dramatically improved. Bilirubin reduced from 18 mg/dL-1.2 mg/dL. Liver enzymes and gamma-glutamyl transpeptidase (GGT) became normal after being in the thousands. The woman's edema disappeared and the tumorous mass showed a 90% reduction. At last account, the woman continued to do well using Bindweed, MPGC, and pancreatic enzymes.
• Colon cancer: A man with colon cancer, having a 5-cm perispinal and a 6-cm pericervical metastasis, was scheduled for radiation therapy. After using Bindweed and MPGC for 5 weeks, the large neck metastasis disappeared.

Suggested dosage: As therapy, Neil Riordan, scientist/spokesperson for the center, says that it appears better to start with an initial high dose, that is, 6 capsules a day of Bindweed (250 mg) and 6 of MPGC (containing 250 mg of lactobacillus fermentum and 50 mg of beta 1,3 glucan). For maintenance, use 4 capsules a day of both Bindweed and MPGC. A critical judgment has to be made in regard to how long to keep a patient on the therapy and at what dosage.

Oral doses of Bindweed displayed no acute toxicity at 20,000 mg/kg (well above the therapeutic range); MPGC showed no acute toxicity at amounts > 5000 mg/kg. Although these products display extremely low toxicity profiles, this regime should be used with the supervision of a physician. In particular, pregnant and nursing women, as well as individuals with active wounds or heart disease, should exercise caution. Various inflammatory conditions, such as autoimmune problems, could possibly be made worse by supplementation. It is suggested that patients discontinue Bindweed 2 weeks before and after surgery.

Warning: Field bindweed (Convolvulus arvensis) contains several alkaloids, including pseudotropine, and lesser amounts of tropine, tropinone, and meso-cuscohygrine, and is toxic to mice. Mice fed only field bindweed had severe hepatic necrosis and gastritis with ulceration or erosions and eventually died. Mice fed low doses of bindweed along with standard laboratory mouse diet for 6 or 8 weeks had no clinical disease or gross lesions on necropsy examination but did have histologic lesions of mild multifocal hepatitis and gastritis (Schultheiss et al. 1995).

These products can be purchased from Aidan, Inc. by telephone at (800) 529-0269. Bindweed is sold as C-Statin and MPGC is sold as ImmKine. (A tape authenticating material presented is available at Allergy Research, [800] 545-9960.)

BURZYNSKI CLINIC

Antineoplaston Therapy, a Therapy Unique to the Burzynski Clinic
Although under ongoing scrutiny, a Texas clinic (run by Stanislaw Burzynski) continues to treat many afflicted with terminal cancer. After 20 years of testing and more than 3000 patient trials, anti-neoplastons have emerged as a means of confronting some types of cancer. Dr. Burzynski explains that anti-neoplastons, small peptide and amino acid derivatives, regulate the cancer process through gene manipulation.

Reducing a remarkably complex disease to one of simplistic nature, cancer occurs when genes that regulate cell growth become dysfunctional. For example, oncogenes (genes involved in cell growth) and tumor suppressor genes (genes that turn off replicative mechanisms) lose their biological control. With cell division up-regulated and tumor suppressor activity down-regulated, cancer takes control. Antineoplastons, the core of the Burzynski program, reestablish cellular control by reducing rampant cell division and activating a tumor suppressor gene. With the cells' replicative patterns restored, the tumor typically shrinks and (in some cases) dies.

ras Oncogenes are involved in the genesis of approximately 40% of all cancers. The simplest anti-neoplaston (phenylacetate) is capable of turning off the signal sent by ras oncogenes, curtailing the constant multiplication of malignant cells. It appears phenylacetate also regulates the activity of p53, a tumor suppressor gene (Bland et al.1998) (please refer to the protocol on Cancer Treatment: The Critical Factors to learn more about Ras oncogenes, as well as tumor suppressor genes). Unlike traditional cancer therapies that kill both healthy and diseased cells, antineoplastons have no significant side effects. The intent of antineoplastons is not to poison the cell, but rather to restore genetic awareness, normalizing cell growth. Natural medicine aims to treat the cause of the disease, not the result; this is the precise logic behind anti-neoplaston therapy.

The Burzynski protocol is safely given to patients 24 hours a day. The therapy is delivered intravenously through a catheter inserted in a central venous line. A pump infuses the medications at scheduled intervals, with the dose and dosing schedule dependent upon the type of cancer. The pump and the therapy bags are small and light enough to be carried around by even a young child. The length of treatment depends on the patient's response. When patients achieve a complete response of long duration, IV therapy is discontinued and the therapy is then administered in capsule form for an additional 8-12 months.

Dr. Burzynski (of international renown) has particular success with non-Hodgkin's lymphoma, as well as two brain cancers: glioblastoma multiforme and astrocytoma, both extremely difficult to control using conventional therapy. Patients with brain tumors had a rate of survival and complete and partial remissions 7 times greater than successes recorded to surgery, radiation, or chemotherapy. As an example, a clinical trial of mixed glioma showed that half of the patients responded to anti-neoplastons. Patients had to have at least a 50% reduction in the size of their tumors to count as responders. Twenty-five percent of those patients had their tumor disappear completely although conventional chemotherapy is virtually useless against this type of cancer (Mouscher 1997).

Although many patients attest to their good health because of anti-neoplaston therapy, Dr. Burzynski has been forced to engage the FDA and the Texas Medical Society, as well as the American Cancer Society and the National Cancer Institute. Because of the politics of medicine, nontraditional oncologists face an ongoing struggle to prove their professional and personal worth.

BURZYNSKI CLINIC
9432 Old Katy Rd., Suite 200
Houston, TX 77055
(713) 335-5697 or (713) 335-5699

GONZALEZ CANCER THERAPY

Proteolytic Enzymes--Diet, Supplements, and Detoxification
The following overview of the Gonzalez nutritional/metabolic program should not be interpreted as a complete account of the therapy, nor as a pattern for treatment. Cancer is a deadly disease; without professional guidance, the odds favor treatment failure.

Various scientists/physicians have devoted the entirety of their professional careers searching for nontoxic solutions to cancer. Instead of being heralded for their incredible commitment and personal sacrifice, accusations have often been threatening and accusing. Individuals of lesser stature would have abandoned their vision, but a medical martyr stays the course. Dr. Nicholas Gonzalez, a graduate of Cornell Medical College with postgraduate training at Vanderbilt University, has (after countless personal attacks) emerged on stronger footing than at any time in his committed career. The once castigated oncologist is now in demand, and doctors at one time hostile to his treatment (on occasion) refer patients and family members for his help.

Dr. Gonzalez shares his concept of treating cancer with several pioneers, that is, Robert Beard (a Scottish embryologist), Francis Marion Pottenger (who in 1919 authored Symptoms of Visceral Disease, a landmark contribution describing the activities of the autonomic nervous system), and William Donald Kelley, a Texas orthodontist who (using Beard/Pottenger logic) developed a remarkably successful nutritional and metabolic approach to treat cancer. Kelley treated himself for undiagnosed pancreatic cancer and 20 years hence was applying the same principles, caring for hundreds of terminally ill patients.

Dr. Gonzalez, inherently interested in the nutrition/cancer link, was invited to investigate Dr. Kelley's files. Perusing the case histories of more than 1000 patients and contacting scores of those numbers, Dr. Gonzalez discovered that hundreds of patients (with terminal disease) were alive 5, 10, and 15 years following diagnosis.

The men (Kelley and Gonzalez) were at opposite ends of their careers. Kelley's work had not been accepted by orthodoxy; in fact the therapy was denounced by the American Cancer Society and put on the unproven-methods blacklist. Constantly castigated, stripped of his license, and weary, he renounced his practice and fled Texas. Dr. Gonzalez, young and bedecked with impeccable credentials (merits Kelley lacked), enthusiastically opened his own office in Manhattan in the late 1980s.

Dr. Gonzalez and Dr. Linda Isaacs (a co-physician), wanting to validate the therapy, compared the outcome of 11 of their patients with inoperable Stage II-IV pancreatic adenocarcinoma to similar patients, who were treated with conventional therapies. Typically, only about 20% of patients with pancreatic cancer survive 1 year, with statistics dropping dramatically thereafter. In a trial using gemcitabine, a costly and debilitating drug, of 126 subjects, not a single patient lived longer than 19 months.

Patients adhering to the Gonzalez program responded far better, and in 1999 he and Isaacs published their data in the peer-reviewed journal Nutrition Cancer (Gonzalez et al. 1999). Although the numbers involved in the study were small, the results were unmistakably impressive: 9 survived 1 year; 5 lived 2 years; 4 survived 3 years; 2 lived 4 years; and 1 survived almost 5 years.

The strength of the Gonzalez/Isaacs study led to a large-scale NCI/NIH funded clinical trial (a 5-year $l.4-million study) conducted by the Columbia Presbyterian Medical Center. This study will compare the effectiveness of a nutritional approach against gemcitabine in patients with advanced pancreatic cancer. The study has full FDA, IND (Investigational New Drug) approval. Half of the participants will receive the best drugs and hospital care available and will be treated by Dr. John Chabot, chief of surgical oncology at Columbia. The others will be placed on the nutritional/metabolic regime and supervised by Drs. Gonzalez and Isaacs. Patients are allowed to choose which treatment they prefer (natural or conventional), but to date it has been difficult to interest patients in enrolling in the chemotherapeutic group: 200 patients inquired and 197 refused the 50% chance of randomization to the chemotherapy arm.

A nutritional/metabolic approach to treating cancer is nontoxic and (though rigorous) does not compare to the stress of conventional compliance. The Gonzalez program requires an aggressive number of daily supplements (130-160 capsules). The pancreatic enzymes (central to the treatment), vitamins, minerals, amino acids, and antioxidants are normally taken for 15 days, then flushed from the system for 5 days, and then started anew.

Coffee enemas, liver flushes, and a whole-body purge with psyllium husks, which Dr. Gonzalez calls "the clean sweep," are essential to the success of the program. It appears that critics have singled out the coffee enemas as the area of greatest contention. Dr. Gonzalez depends upon coffee enemas (detoxification) to assist the body in processing enormous amounts of toxic debris that can be produced as tumors break down. Few are aware that from 1899-1977 coffee enemas were included in the Merck Manual, a compendium of orthodox research techniques. Coffee enemas were not removed from the Manual because of their ineffectiveness, but rather to make room for newer material.

One of the many nutritional therapies utilized by Dr. Gonzalez is proteolytic enzymes. Scientific and clinical studies corroborate the benefits of enzymes in the maintenance of good health and the management of age-related frailties. For example, researchers in Austria found that enzymes help maintain healthy levels of transforming growth factor-beta (TGF-beta). TGF-beta plays an important role in the body's ability to repair and heal itself, but excessive levels of TGF-beta, trigger abnormal growths that can give rise to cancer. Drs. Lucia Desser (Institute for Cancer Research, University of Vienna) and Karl Ransberger (Mucos Pharma, Munich, Germany) studied the effect of enzymes on TGF-beta, and found that pancreatic enzymes consistently brought levels back into the normal range (Blobe et al. 2000).

Proteolytic enzymes also reduce the stickiness of cancer cells and the progression of metastasis. The sticky nature of cancer is thought to be initiated by an enzyme deficiency, resulting in excessive fibrin production, a protein having the nature of barbed wire. Fibrin performs another task that strongly favors the tumor. As fibrin forms on the tumor cell membrane, it cloaks the tumor in a protective barrier, making tumor recognition extremely difficult.

The close relationship between fibrin deposits, invasive tissue growth, and metastasis is well-documented and generally accepted. For example, the European Journal of Cancer reported on the adhesiveness of cancer cells in the article "No Grip, No Growth" (Reijerkerk et al. 2000). Overcoming the inherent traits of cancer (cell adhesion or stickiness, migration, proliferation, and survival) are functions specific to proteolytic enzymes.

Proteolytic enzymes are powerful anti-inflammatories (Maurer 2001). The Life Extension Foundation has been deliberate, instructing members that systemic inflammation is instrumental in initiating most cancers. The endothelium of tissue displaying inflammatory alterations (a thickened layer of adhesion molecules) is a site for metastasis. As proteolytic enzymes reduce inflammation, the risk of metastasis is further reduced. The literature (largely) shows that proteolytic enzyme therapy extends survival (from months to years) in patients with both blood borne and solid tumors (Golaszewski et al. 1997; Lokshina et al. 1993).

Dr. Gonzalez accepts post-chemotherapy patients, but the nutritional/metabolic program is not implemented in tandem with other treatments. For further information or to determine eligibility for a trial, contact Michelle Gabay, R.N., at (212) 305-9468 or visit the Gonzalez Web site. Dr. Gonzalez treats all types of cancers; pancreatic cancer was selected for ongoing clinical trials because of the poor survival rate of patients with this malignancy.

RADIOFREQUENCY ABLATION (RFA)

High-frequency electric current is being used to heat tumors from within (Gazelle et al. 2000). In cardiology, high-frequency radio waves have been used for decades to ablate cardiac nerves in patients with dangerous heart rhythms that resisted drug therapy. The concept segued into oncology with radiofrequency ablation (RFA) initially used to provide palliative relief to inoperable, terminal patients, particularly those with liver cancer (Branda et al. 2003).

But momentum is growing for this technique, and the therapeutic focus is changing. So strong are the prospects for RFA that this pioneering treatment appears (according to researchers) to have the potential to replace both surgery and radiation therapy. Because of its therapeutic value and cost effectiveness, along with its noninvasive, low-risk profile, RFA has the attention of both physicians and patients. The National Institutes of Health consider RFA the most predictable, safest, and simplest method for thermal ablation in bone, liver, kidney, prostate, breast, and brain cancers.

Using open MRI, doctors gain access to the tumor through a needle puncture, a process requiring no surgery. Using specially designed titanium or stainless steel instruments, doctors are directed by the MRI image to the site of malignancy. A titanium electrode is guided to the tumor and enough heat is generated (just below the boiling point) to kill the cancerous cells. After 10-12 minutes of continuous contact with the tumor tissue, the radiofrequency energy "ablates" a sphere of 1-2 inches. By "ablating" adjacent spheres, larger tumors can be treated.

Dr. Jonathan Lewin, director of magnetic resonance imaging at University Hospitals of Cleveland, says that tumorous areas that earlier appeared white are now black, a black hole of dead tumor tissue. It is immediately possible to determine the amount of tumor destruction and to plan treatments (should additional treatment be necessary). The dead cells are not removed, but become scar tissue and eventually shrink. The procedure is done under local anesthesia, with minimal discomfort to patients. There are no cumulative dose effects as with radiation therapy, so patients can be treated repeatedly if the cancer returns to other sites. Hospitalization is usually limited to several hours rather than days.

Dr. Patrick Sewell (University of Mississippi Medical Center) performed this procedure on nine lung cancer patients in China, ranging in age from 38-78 years. Five had primary tumors, two had primary lung tumors with metastasis, and two had metastasized cancer that had spread to the lungs from other locations. When the PET scans came back (3 days following treatment), all tumors had been killed (Sewell 2000).

At the 85th Annual Meeting of the Radiological Society of North America (Chicago), Dr. Tito Livraghi of Vimercate Hospital (Italy) presented the results of a study designed to evaluate the efficacy of RFA in breast cancer-to-liver metastasis. The study consisted of 15 lesions in 10 patients (mean age 51 years). Eight of the patients had progressive metastatic disease following chemotherapy; two patients with hepatic metastasis had not undergone chemotherapy.

Following RFA, the value of the treatment was assessed by biphasic helical computed tomography (CT) performed at 4-month intervals. Complete necrosis was obtained in 14 out of 15 lesions (93%). Follow-up imaging studies (at 4-30 months) were unable to detect a recurrence in any of the 14 lesions. Four patients have remained disease free; five (later) have developed new hepatic and/or extra-hepatic metastasis; and one has died with diffuse metastasis. RFA resulted in no treatment-induced complications (Pullen 1999).

Early results (from an NIH Clinical Center Study) look promising for the use of RF energy in patients with certain kidney and adrenal tumors (Zagoria 2003; Wood et al. 2003). Of 18 kidney tumors treated, 13 (72%) showed no x-ray evidence of residual tumors immediately following treatment. One patient remains cancer-free 2 years following treatment. In a related NIH study involving adrenal gland tumors, 7 of 11 tumors (64%) showed no active disease following RFA. Though the remaining 36% of patients had evidence of residual tumors on follow-up imaging, all patients treated had x-ray confirmation that most of the targeted tumor was killed by treatment (Gervais et al. 2000).

Dr. Steven Curley (University of Texas M.D. Anderson Cancer Center) says that within a 12-month timeframe more data will be available to physicians and patients. But in the interim, Dr. Curley says that inoperable colorectal patients have enjoyed a 3-year survival using RFA. In some cases, RFA is sufficient in itself; for those less fortunate, the process buys the immeasurable gift of time. With the advent of integrated medicine, groundbreaking finds are stockpiling. It is felt that scientists are significantly advancing on this dread disease, and a 3-year reprieve could "just make the difference."

M.D. Anderson Cancer Center
Houston, Texas
Telephone: (713) 792-2121

University Hospitals of Cleveland
Cleveland, Ohio
Telephone: (216) 844-1000

SUMMARY

Although it would be wholly inappropriate for the Life Extension Foundation to steer individuals in decisions of omission or commission regarding therapies, it would be equally improper to shun responsibility. Because we are challenged by a professional and moral commitment to assist in overcoming appalling statistics, we have discussed some controversial issues in this protocol.

Cancer treatment has always resulted in a political battle, even within the confines of conventional medicine. Surgeons, for instance, strongly endorse surgical removal of the tumor(s), although radiologists often recommend various forms of radiotherapy to kill cancer cells. Medical oncologists, on the other hand, are proponents of chemotherapy, immune-augmentative, and hormone modulation therapies. In many cases, a particular type of cancer may warrant utilization of all conventional therapies, that is, surgery, radiation, and chemotherapy.

When it comes to alternative approaches, there are a wide variety of choices that can be accessed on the Internet. The challenge is separating the hype from credible science. The difficulty in achieving control over many forms of cancer has enabled inexperienced practitioners to flourish.

Conventional oncology has long criticized the efficacy of alternative methods. The irony is that the treatments offered at mainstream cancer centers provide little hope for those afflicted with the most deadly cancers. Until a cure is found, there will be a constant political and scientific struggle to capture the attention and gain financially from the 1.3 million Americans who are diagnosed with cancer each year.

The purpose of this protocol is to provide options that would not normally be offered by practicing oncologists. These various alternative therapies raise many issues that are subject to change as new data emerges. Patients are encouraged to check www.lefcancer.org for updated information about reported successes or failures of treatments offered by alternative cancer clinics.

It is important that cancer patients also read the protocols in this book titled Cancer Adjuvant Therapies and Cancer Treatment: The Critical Factors to learn about other potential treatment strategies.

STAYING INFORMED

The information published in this protocol is only as current as the day the manuscript was sent to the printer. This protocol raises many issues that are subject to change as new data emerge. Furthermore, cancer is still a disease with unacceptably high mortality rates, and none of our suggested regimens can guarantee a cure.

The Life Extension Foundation is constantly uncovering information to provide to cancer patients. A special website has been established for the purpose of updating patients on new findings that directly pertain to the published cancer protocols. Whenever Life Extension discovers information that may benefit cancer patients, it will be posted on the website www.lefcancer.org.

Before utilizing this cancer protocol, we suggest that you log on to www.lefcancer.org to see if any substantive changes have been made to the recommendations described herein. Based on the sheer number of newly published findings, there could be significant alterations to the information you have just read.