Immune Augmentation Therapy Detailed Scientific Review
Overview
Background
The theory of Dr. Lawrence Burton, Ph.D., a zoologist, is that cancer cells multiply when four factors of the immune system fail to recognize and destroy them. The four factors which are given in the form of daily self injections are:
Deblocking protein
A protein from the pooled blood serum of healthy donors which is said to remove the tumor "blocking factor" that prevents the patient's immune system from detecting the cancer
Tumor antibody 1
A combination of alpha 2 macroglobulin with other immune proteins (IgG and IgA) derived from the pooled blood serum of healthy donors
Tumor antibody 2
An antibody complement that stimulates the antibody, also derived from healthy donors but differing in potency
Tumor complement
A substance derived from the blood clots of patients with many types of cancer which activates the two tumor antibodies1
Another source defines two of the non-antibody substances as: a "blocking" protein, which inhibits the antibody in order to give the body a chance to clear toxic waste associated with tumor destruction, and an antiblocking protein that inhibits the blocking protein2.
Dr. Burton developed his theory during the 1950s while working with fruitflies at California Institute of Technology. Results of these experiments were questioned and could not be replicated as reported in a 1961 article in Science3. At St. Vincent's Hospital in New York, he and his partner, Frank Friedman, continued these experiments with mice and demonstrated dramatic softening and shrinkage of tumors in mice. At a Scientific Writers Conference in 1966, they received widespread press. An oncologist who later examined the mice stated that "it was obvious that he had massaged the tumors until they had become fluid and then aspirated out the tumor and necrotic material. . . .a fresh puncture wound was found at each tumor site"3. According to the organizer of the conference, such claims were "patently false"1.
Nevertheless, the Immunology Research Foundation was established in 1973 in Great Neck, New York. More than 100 patients were treated there by the late 1970s. An investigational New Drug (IND) application was filed, but not granted by the FDA. The clinic closed in 1977 and later that same year the Immunology Researching Centre, (IRC) Ltd. Freeport, Grand Bahamas, was established3.
In 1985, two laboratories in the State of Washington tested samples of the serum proteins obtained from two patients who had attended the clinic and isolated the Human Immunodeficiency Virus (HIV) (formerly called HTLV). Following a visit in July of 1985 by the Bahamian Ministry of Health and the Pan American Health Organization, the clinic was closed4. During that period, a congressional public hearing sponsored by Congressman Guy Molinari was held. Following testimonials from patients, support from the Congress, and an agreement to follow conditions set by the Bahamian government, the clinic was allowed to reopen in 1986. Although all serum is tested for contamination, individuals are not allowed to bring any of the blood products into the United States.1,3,5.
At the request of Congressman Molinari and cosigners, the former Office of Technology Assessment (OTA) formed a working group with the IRC to develop a clinical trial. (Between 1972 and 1995, the OTA provided Congressional members and committees with analyses of scientific and technical issues.) The IRC proposed an evaluation of patients with peritoneal mesothelioma who did not have advanced disease. Because of the rarity of this disease and other difficulties, the OTA proposed a randomized phase II trial of patients with more common cancers. Despite numerous meetings and proposals, the groups could not reach an agreement on a protocol apparently due, at least in part, to a misunderstanding concerning a proposed pre-trial3.
Proposed Mechanism of Action
It has been suggested that the tumor antibodies attack the tumors and the deblocking proteins remove the 'blocking factor' that prevents the patient's immune system from detecting the cancer.
Toxicity
As stated on page 137 of the OTA report…"as with any human blood products, IAT poses some risk of infection to patients which could be minimized with appropriate manufacturing practices, product testing, and donor screening"6.
More information on the science and research in Immune Augmentation Therapy is provided in the Summary of Research.
Summary of Research
Amount and Type of Research
Based on our review of the literature and other sources between 03/01/2005 and 05/15/2007, no new references were identified.
Based on our past reviews of the literature and other sources between 11/01/97 and 02/28/2005, we did not identify any new references to "Immune Augmentation Therapy" or to "Immuno-augmentative therapy". A previous search ending 10/31/97 hadidentified 49 references, of which 38 (78%) were applicable to cancer. The articles retrieved is33 (87%) and these references are classified into the following types of information:
| Human | Animal | In vitro | Reviews | Other |
|---|---|---|---|---|
2 | 3 | 0 | 1 | 27* |
*Note: One article was obtained from a general review of multiple complementary/alternative therapies3.
Of the human related articles, we coded the studies (2) by the following study designs:
Study Design | No. of Studies |
|---|---|
Randomized Controlled Blinded Clinical Trial | 0 |
Randomized Controlled Clinical Trial | 0 |
Non-Randomized Controlled Trial /Prospective Cohort | 0 |
Controlled trial/Prospective Cohort with Historical (Literature) Controls | 0 |
Prospective Cohort/Clinical Series/ Trial with No Controls | 1 |
Case-Control Study | 0 |
Retrospective Cohort with Historical Controls | 0 |
Retrospective Cohort with No Controls | 0 |
Best Cases | 0 |
Case Report | 1 |
Total Human Studies | 2 |
Summary of Human Research
A review of the literature identified two articles on IAT. One was a best case report on 11 patients with pathologically confirmed peritoneal mesothelioma6. IAT was injected and survival was assessed. The patients reported a mean survival of 30 months, ranging from seven to 80 months. This was compared to a survival range of one to 60 months in the literature.
In the second article, 79 patients with metastatic disease who had taken IAT were surveyed by phone to assess survival. Fifty were alive an average of 65 months after diagnosis; the 29 that died survived an average of 59 months. Some patients reported quality of life improvement7. No statistics were reported in this article.
This table provides brief notes concerning these two studies.
IAT Summary of Human Studies Table
Annotated Bibliography
Human Studies
7Cassileth, B.R., et al. Report of a survey of patients receiving immuno-augmentative therapy. (Unpublished study cited in OTA Report3.)
Purpose: To compare survival and quality of life
Type of Study: Clinical series
Methods: In 1987 Cassileth and colleagues surveyed IAT patients by telephone. The study was initially designed to compare survival and quality of life between matched pairs of patients with metastatic cancer (a patient from the Pennsylvania Cancer Center was to be matched with each IAT patient). Because few IAT patients met the eligibility requirements, a matched analysis was not performed. A total of 79 IAT patients were studied with data collected from 54 patients and 25 next of kin. In their survey, Cassileth and colleagues asked the patients about results of any HIV or hepatitis B tests.
Results: Of 23 patients tested for hepatitis B antibody, four tested positive. Of 24 patients tested for the HIV antibody, one reported a positive result. About a third reported being more ambulatory and another third reported improvement in appetite following first visit to the clinic. One half reported no change in their performance status. The patients in the study began IAT an average of 17 months after diagnosis and 50 of the 79 patients (63%) were alive an average of 65 months after diagnosis. The 29 deceased patients survived an average of 59 months.
Note: Cassileth and a biostatistician reviewer John Bailar concluded that the quality of life questionnaire used "may have been seriously flawed and inadequate". Bailar emphasized that the survival time information is unusable in the absence of some appropriate comparison.
6Clement, R.J., et al. Peritoneal mesotheliomas.
Purpose: Compared survival of (n=11) peritoneal mesotheliomas
Type of Study: Case reports
Methods: (Malignant mesothelioma) Subject population consisted of four females and seven males. Each of these cases were reviewed and analyzed. The patients had previous histological confirmation of diagnosis at laparotomy or subsequent confirmation at autopsy and a pattern of clinical responses compatible with malignant peritoneal mesothelioma. Upon assessment of the immuno-competence of the patients all 11 of them demonstrated a characteristic immuno-profile with elevated titers of pre-albumin blocking protein factor and suppressed levels of an alpha 2 macroglobulin deblocking protein factor. All of the patients were given immuno-augmentative therapy by subcutaneous and intramuscular injection of human serum protein components derived from volunteer donors without neoplastic disease and of tumor complement factor derived from human serum of the persons with malignant mesothelioma.
Results: All eleven subjects demonstrated a common response: weight gain and an increase of endurance for physical activity. Four males and one female were alive with survival times ranging from 22 to 80 months, with a mean of 43 months and median of 52 months. Of the other six cases mean survival was 23 months and median was 16 months, with a range of seven months to 50 months. The total subject population represents mean survival of 30 months with a range for all cases from seven months to 80 months. Authors compared these survival times to five reported series in the literature, ranging from one to 60 months.
Reference List
- Moss R. IAT. Cancer Therapy: The Independent Consumer's Guide to Non-toxic Treatment and Prevention. Brooklyn, NY: Equinox press, 1992:476-83.
- Null G. Cancer: Dr. Burzynski. Gary Null's complete guide to healing your body naturally.McGraw-Hill Book Company, 1988:95-107.
- U. S. Congressional Office of Technology Assessment, Archived at Princeton University. Immuno-augmentative therapy chapter. [Web Page]. 1990. (Accessed 2007 May 17)
- U. S. Department of Health and Human Services PHSCfDC. Isolation of human T-lymphotrophic virus type II/Lymphadenopathy-associated virus from serum protein given to cancer patients. MMWR 1985;34:489-91.
- Workshop on Alternative Medicine. Alternative Medicine: Expanding Medical Horizons. A Report to the National Institutes of Health on Alternative Medical Systems and Practices in the United States. Washington, DC: US Government Printing Office, 1992.
- Clement RJ, Burton L, Lampe GN. Peritoneal mesothelioma. Quantum Medicine: A Journal of Comparative Therapeutics 1988;1:68-73.
- Cassileth BR, Trock BJ, Lusk EJ, et al. Report of a survey of patients receiving Immuno-augmentative therapy. Unpublished Study 1987 Sep.