Therapeutic Treatment Procedures

The Immune Recovery Clinic of the Immune Recovery Foundation

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The IRF Clinic's approach is quite different from that of other clinics. We use immune therapy whenever possible. The lack of popularity of immune therapy in general oncology comes more from the way it is usually employed and not its potential. Approval for all drugs, including those for cancer, comes only after rigorous clinical trials following the guidelines set by regulatory agencies, such as the FDA. They have so far mostly mandated that immune therapy only be tested after failure of conventional chemotherapy. At this point the patient suffers from severe immune depression, a result from both the cancer as well as the prior treatments. Under these conditions it is remarkable that any activity is ever seen. Whenever immune therapy can be used as a first-line treatment, before chemotherapy, radiation or in some cases surgery, it presents a more active face.

1. The Clinic's approach is to first correct the immune deficiencies found in the patient and only then apply other treatment modalities. Usually these patients also require detox, a procedure to remove cellular breakdown products in the blood. Many of our treatment protocols require a functional immune system for optimal activity. Immune restoration is accomplished through high dose ascorbic acid / B-complex vitamins, selected minerals, proprietary use of certain biologicals (beta glucan, BCG, transfer factor, natural agents) and conventional drugs. This correction alone will often start an immune anti-tumor action.

2. Once immune correction has been accomplished, the immune system can be stimulated to intensify this activity. This can be done in a variety of ways using selected cytokines such as Il-2, alpha interferon, tumor necrosis factor, GM colony stimulating factor and others. The goal is to elicit a tumor rejection reaction, similar to a tissue transplant rejection. Older terminology classified this as a delayed hypersensitivity reaction.

3. Procedures such as anti-cancer vaccines can also be given at this time when deemed appropriate. These immune stimulating procedures often work in concert with vaccines, each augmenting the other. Several types of vaccines are available, some are made from the patient’s own tissue or blood components, whereas others are generic vaccines produced through use of cancer tissue grown in tissue cultures, such as the Hasumi vaccine. The variable or sometimes lack of activity seen with these vaccines in general clinical settings is most likely the result of their usage in patients that are immuno-suppressed and therefore unable to respond to treatment. We only employ vaccines in immuno-competent or immuno-restored patients.

4. Dendritic cell therapy utilizes the patient’s blood as a source of cells, which are multiplied by cell culture, antigenically stimulated and then re-infused into the patient. This is another procedure that shows promise, yet for optimal activity it requires a functioning immune system. These procedures have characteristically been available outside the US. When appropriate, we can refer patients to several such clinics.

5. A procedure which uses the patient’s own lymphocytes (white cells) to produce a natural mixture of cytokines is available at a Mexican clinic but not yet in the U.S. These cytokines are considered more active than the recombinant cytokines mentioned in 2. (above) and closely resemble natural cytokines used in clinical trials, but they are not yet commercially available.

6. IPT. Conventional chemotherapy is contraindicated with immune therapy because it reduces or blocks the immune activity. However, low doses of a chemotherapeutic agent given more frequently can often be used with immune therapy. The lower dose has little or no effect on the immune system in the short term. In fact, low doses of certain chemotherapeutic agents can actually block the so-called inhibitory arm of the immune system (as production of suppressor T-cells), which is a desired effect with some immune therapy. In order for the chemotherapeutic agent to show good anti-cancer activity it must be used in concert with other agents which in turn boost the anti-cancer effect without increasing immune suppression. One such agent is insulin, and it is used in the so-called Insulin Potentiation Therapy (IPT, see below). Recent literature suggests that immune therapy (cytokines) also potentiates the activity of chemotherapy agents.

Antiangiogenesis:

For a tumor to grow and metastasize it must have a blood supply. Angiogenesis is the process by which new blood vessels, called capillaries, develop and grow. Angiogenesis occurs naturally in reproduction, in the development of the embryo, and in the healing process of wounds. Angiogenesis also occurs in several unnatural, pathological conditions such as rheumatoid arthritis, diabetic retinopathy, and cancer. In the case of cancer, a tumor will not grow larger than 0.5 mm unless it obtains an ever increasing blood supply through the angiogenic process.

Tumors require an extensive network of blood vessels to supply the nutrients for its excessive cell growth. Thus, the tumor calls on many of the body mechanisms to acquire those needed blood vessels. If the tumor can be denied this continuing supply of new blood vessels, tumor growth will be inhibited or halted. Treatment to block angiogenesis is properly termed antiangiogenesis (AA). It must be emphasized that antiangiogenesis will most likely not “cure” cancer. It will slow or halt growth, which in turn will allow more time and opportunity for other cancer treatments to become effective.

Endothelial cells line blood vessels, The tumor produces angiogenic substances to initiate endothelial cell growth, which in turn initiates capillary growth. These substances may be growth factors particularly VEGF- vascular endothelial growth factor, proteases, oncogenes, signal transduction enzymes, cytokines, endogenous modulators, etc.

Many natural and alternative medicines are proposed to have AA activity, which may explain in part, why they show anticancer activity. The mechanisms of activity remain to be elucidated. Some of the products claimed to have AA activity are: alpha lipoic acid, bindweed, butcher’s broom, curcumin, genistein, green tea, honeylocust fruit, quercetin, selenium, shark cartilage, and silimarin.

There are two general approaches to antiangiogenetic therapy. One is to block these growth factors; there are several such blocking agents, such as Avastin, being developed by various drug companies. They are in clinical trial and show promise, and also promise to be expensive if and when available. Further, as with many new drugs, adverse effects are being found, which may not outweigh their potential in cancer therapy. These drugs are currently for clinical trial only, and access requires participation in such trials.

A second approach is to deny a tumor the one component absolutely required for blood vessel growth - copper. Tumors hoard copper containing about three times the normal tissue levels of this mineral. Normal tissue function remains intact when the copper levels are only lowered but a tumor’s abnormal needs are denied. Unlike the first approach , there is already a drug available. An agent with orphan drug status for the treatment of Wilson’s disease is available and works by decreasing body copper levels. Tetrathiomolybdate (TM) selectively chelates copper and has been safely used for many years in the treatment of Wilson’s disease. Initial studies indicate that it can decrease cancer cell growth. There are at least nine clinical trials of TM in progress, and these trials will attempt to prove activity in several cancer types.

Tetrathiomolybdate treatment requires a month or more to reduce copper levels; then the patient must be maintained at this low copper level for several months. As with all cancer treatment, the sooner treatment starts the more likely there will be success. The treatment procedure is rigorous with regard to dosage timing, diet, and other restrictions. This is not a treatment to be individually undertaken. We cannot over stress the absolute need for patients using TM therapy to be in the care of a physician and be continually monitored for the duration of the treatment. Drug adjustments will likely be required over time to maintain the desired effect. As adjuvants to TM treatment, both vitamin C and zinc,if taken with meals, will decrease copper uptake.

We feel that TM will become a major component of successful cancer therapy in both conventional and alternative medicine. However, we also feel that TM’s potential will only be realized when TM is rationally combined with other modalities, both while copper levels are being lowered, and later when the low copper level is being maintained. Time is never on the side of the cancer patient. If cancer growth can be slowed or halted, this offers more time as well as opportunity for other therapies to actually kill the cancer. We feel that immune therapy will be greatly improved when combined with antiangiogenesis. It is also likely that some alternative treatments will show sufficient activity under these conditions to demand they be recognized.

Insulin Potentiation Therapy (IPT):

Insulin Potentiation Therapy (IPT), sometimes referred to as Low Dose Chemotherapy, is a controversial cancer treatment procedure originally practiced by Dr. Donato Perez Garcia and continued by his son, Dr. D. Perez Garcia Bellon. IPT must be distinguished from those procedures that employ lower doses of chemotherapy on a daily basis and do not use insulin as part of the treatment. There is disagreement whether low dose chemotherapy is overall more effective than high dose chemotherapy.

The primary thrust of low dose chemotherapy is to reduce the incidence and severity of the severe side effects of chemotherapy. Critics worry that the long term effect may lead to an early resistance of the cancer to the chemotherapy agent. Resistance usually always occurs in conventional high dose chemotherapy, so the argument is really which treatment will kill proportionally more cancer cells and how much more time will the patient gain before the drug becomes ineffective. Can the low dose approach result in a remission of the cancer and how long will it last? A critical question should also be; what is the patient’s quality of life during the time gained by both of these approaches?

Research on the low dose regimen is in progress and has sufficient financial backing to provide some answers to these questions. The use of this treatment regimen in early stage cancer patients will determine the true effectiveness, if any, of this approach.

Immune Recovery Clinic is interested in the low dose approach, because it potentially may offer less immune damage than the high dose treatment. Thus, it would allow a simultaneous treatment with chemotherapy and immune therapy. Theoretically, low dose chemotherapy combined with immune therapy makes sense. However, to date there is no evidence to support or deny this possibility/combination.

Insulin Potentiation Therapy (IPT) combines the low dose approach with the additional activity of insulin. The original theory in simplified form is as follows:

“Cancer cells have high metabolic rates because they are growing, and cancer cells can only use glucose as an energy source. Thus, cancer cells have more insulin receptors on the cell surface and will have a more intense reaction to insulin than normal cells. Therefore, if the patient is given insulin, the blood glucose level will go down and the cancer cells will momentarily be starved for glucose. If both glucose and a chemotherapy drug are given while the cells are starved for glucose the cancer cell membranes will open for glucose and more of the chemotherapeutic agent will also enter the cell. Under these conditions a lower dose of chemotherapy will be as effective as a high dose.”

IPT has been around since the 1930s. Its use has been widely criticized because (1) it does not have a mechanism of action acceptable to current scientific dogma, (2) it does not have comparative clinical studies to support its claims, and (3) it was not invented in the US. Under the original concept the patient’s blood glucose level would be dropped to the level of insulin shock; then, the chemotherapy agent and glucose would be administered. This can be without question a dangerous procedure unless carefully administered. Physicians have justified this approach by saying it was no more dangerous than a high dose chemotherapy regimen that brought with it its own mortality rate. More recently the IPT approach has been modified by some so as not to drop the patient’s blood glucose level to the point of sending the body into insulin shock. While this more recent regimen has avoided the insulin shock problem, it has not yet resolved the primary question – is IPT as effective, or more effective than high dose chemotherapy? There are no studies comparing low dose to high dose chemotherapy that meet the“ FDA type standards.”

Just as there are no controlled studies to show the effectiveness of low dose chemotherapy, there are no such controlled studies for IPT. If IPT is to be proven effective, its greatest utility would be in the initial treatment of cancer, and not after all other options have been tried. Today’s standard regulatory approach is to try new therapies last, after other treatment options have failed. At that time, unfortunately, the most effective chemotherapeutic agents to fight a particular cancer will have failed, and, therefore, there would be no reason to believe that IPT would now render these agents active once more. Thus, any such study of IPT under present guidelines would be biased against IPT. This is also true for immune therapy, where the guidelines dictate that immune therapy is tried last, after chemotherapy and radiation have totally destroyed the immune system. Thus, any study conducted of either approach under the conventional guidelines is guaranteed to fail.

Immune Recovery Clinic has extensively reviewed the information on low dose chemotherapy and insulin. We believe that IPT, as it is currently used, is an effective alternative to high dose chemotherapy. We agree that data supporting IPT is not available, namely the kind of data the scientific community desires. However, there are also no data to reject IPT outright. We have examined the current procedures of Dr. Donato Perez Garcia Bellon and find they have the potential to become an accepted treatment. We also believe that incorporating IPT and immune therapy in an individualized protocol has much promise. Many patients will opt for IPT after having exhausted all conventional options, although they might not be the ideal candidates for this treatment procedure. However, there is evidence that immune therapy can sensitize some cancers to chemotherapy. Therefore, this treatment combination may aid even those patients, who did not initially respond to chemotherapy.

Immune Recovery Clinic strongly believes that any procedure for chemotherapy which avoids immune damage should be utilized. A concerted attack on cancer cells from several approaches offers more promise of success. There are reports of immune therapy facilitating the activity of both radiation and chemotherapy. We feel that the potential of immune therapy as a first stage treatment of cancer is essentially being ignored by the medical community. The combination of immune therapy and IPT deserves careful consideration.

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