Cancer Treatment Today » Alternative/Complimentary

Immunoaugmentative Therapies (IAT) – pro

M Levin, MD — Mon, 13 Aug 2012 17:54:53 +0000

The treatment described is in the province of alternative medicine and not allopathic medicine. The theory for the treatment that is described does not ‘fit’ allopathic physiology.

Immuno-Technologies Cancer Clinic (ITL) is located 30 minutes (by plane) from Miami in Freeport, Bahamas. The Clinic and the alternative cancer treatment research center is directed by Dr. John Clement.

Each alternative cancer treatment plan is customized to the person with cancer. In addition to immune therapy such as cancer vaccine we provide angiogenesis inhibition (blocking new blood vessels that feed tumor), apoptosis inducing agents (help tumor cells to commit suicide), and cytotoxic agents that kill tumor cells while not destroying normal cells, including photodynamic therapy (a dye made from chlorophyll accumulates in the tumor, and a light is applied to activate the dye to kill the tumor).
Immuno-augmentative therapy (IAT) was developed by Lawrence Burton, Ph.D., a zoologist who claimed that it could control all forms of cancer by restoring natural immune defenses. He claimed to accomplish this by injecting blood serum proteins isolated with processes he had patented. However, experts have shown that the substances he claimed to use cannot be produced by these procedures and do not exist in the human body. During the mid-1980s, several of Burton’s patients were reported to have developed serious infections following IAT. Burton died in 1993, but the Bahamian clinic he founded is still operating under the direction of Dr. R. John Clement, a British-trained general practitioner who joined with Burton in 1978.

No evidence has been published showing that immuno-augmentative therapy is safe or effective against cancer in humans. Burton did not publish detailed clinical reports or meaningful statistics, divulge the details of his methods, conduct a controlled trial, or provide independent investigators with specimens of his treatment materials for analysis. The mechanism of action he postulated for his treatment

involved substances that are unknown to the scientific community. Although Burton said that IAT treatment materials were produced with processes he patented, experts do not believe that these processes can achieve what he claimed. Several attempts to develop a protocol for a clinical trial of IAT were unsuccessful.

July 29, 1974 cover of New York Magazine.

“After studying the literature and other available information, the American Cancer Society has found no evidence that the “immuno-augmentative therapy (IAT)” advocated by Lawrence Burton, PhD, is safe or results in objective benefit in the treatment of cancer. Lacking such evidence, the American Cancer Society strongly urges individuals with cancer not to seek such treatment.” (CA 1991)

A 2003 RAND Corporation review of patient cases concluded: ”

“The IAT cases provide sufficient indications for the recommendation that IAT warrants further study . . . For IAT, this review suggests there is sufficient evidence to recommend that either a random controlled trial or a prospective case series could be considered.”

A book: about IAT: here

Spencer JW, Jacobs JJ. Complementary/alternative medicine: an evidence based approach. Toronto: Mosby, 1999:149.

Bernd L. Pfeifer, MD, PhD Wayne B. Jonas, MD
Clinical Evaluation of “Immunoaugmentative Therapy (IAT)”: An Unconventional Cancer Treatment Integrative Cancer Therapies, Vol. 2, No. 2, 112-119 (2003)

Coulter, I., Hardy, M,, Shekelle, P., et al. Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer. Evidence Report/Technology Assessment No. 78 (Prepared by Southern California-RAND Evidence-based Practice Center under Contract No 290-97-001). AHRQ Publication No. 03-E030. Rockville, MD: Agency for Healthcare Research and Quality. April 2003.

Insulin Potentiation Therapy – pro

M Levin, MD — Mon, 13 Aug 2012 17:53:02 +0000

Insulin potentiation therapy (IPT) refers to the use of insulin along with lower doses of chemotherapy to treat cancer. It is also sometimes used with other types of treatments for chronic diseases.

IPT was developed in Mexico by Dr. Donato Perez Garcia, Sr., around the same time insulin had begun to be used in schizophrenics. In fact, some of those who support IPT note that, at this early stage, patients with cancer were also put into an insulin coma. Dr. Perez used this technique to try to treat several types of cancer. His son, Donato Perez Garcia Bellon, and grandson, Donato Perez Garcia, Jr., have followed in his footsteps. A physician from the United States, Dr. Steven G. Ayre, is a supporter of IPT and has published some descriptions of the theory behind it.

One very small published study that looked at IPT was done in Uruguay. It included 30 women with breast cancer that was resistant to mainstream therapies. Of these women, 10 got insulin alone, 10 got methotrexate (a chemotherapy drug) alone, and 10 received IPT using both drugs. After 8 weeks, the researchers reported that the women in the IPT group had smaller increases in tumor size than either of the other groups. Even though they used lower doses of methotrexate than usual, there were some side effects (mouth sores) noted in the IPT group. This study did not look at survival, quality of life, well being, or lasting effects. No long-term improvements were shown by this study.

Most of the information about IPT comes from individuals (anecdotal reports.) Even among these, however, there is no evidence that the people who report being helped by IPT were followed up long enough to find out if the treatment worked.

There are also concerns about using lower doses of chemotherapy drugs. When chemotherapy drugs are tested in clinical trials, their effects are carefully monitored to learn which dose will have most effect on the cancer while keeping the side effects as low as possible. There is no evidence that chemotherapy at a fraction of the recommended (tested) dose can produce the same effect as the full dose if insulin is used with it.

Ayre SG, et al. Insulin, chemotherapy, and the mechanisms of malignancy: the design and the demise of cancer. Med Hypotheses. 2000 Oct;55(4):330-4.
Leroith D, Roberts C. The insulin-like growth factor system and cancer. Cancer Lett. 2003 ;195(2):127-37.
Benini S, et al. Inhibition of insulin-like growth factor I receptor increases the antitumor activity of doxorubicin and vincristine against Ewing’s sarcoma cells. Clin Cancer Res. 2001 ;7(6):1790-7.
Ayre SG, et al. Insulin potentiation therapy: a new concept in the management of chronic degenerative disease. Med Hypotheses. 1986 ;20(2):199-210.
Ayre SG, et al. Neoadjuvant low-dose chemotherapy with insulin in breast carcinomas. Eur J Cancer. 1990;26(11-12):1262-3.
Albaster O, et al. Metabolic modification by insulin enhances methotrexate cytotoxicity in MCF-7 human breast cancer cells. Eur J Cancer Clin Oncol. 1981 ;(11):1223-8.
Holdaway IM, Friesen HG. Hormone binding by human mammary carcinoma. Cancer Res. 1977;37(7 Pt 1):1946-52.
Renehan AG, et al. Insulin-like growth factor (IGF)-I, IGF binding protein-3, and cancer risk: systematic review and meta-regression analysis. Lancet 2004;263: 1346-53.

L.E.I.S.H. – pro

M Levin, MD — Mon, 13 Aug 2012 17:51:30 +0000

The LESIH procedure relies on the use of a proprietary LASER System, of a wavelength not significantly absorbed by human tissue and emitting a low power broad beam. It is a form of fractionated Photo-dynamic Therapy.

Both Photo-dynamic Therapy and Radio-fractionated Hyperthermia are FDA approved; however, due to limitations in the available delivery equipment, they cannot be utilized to treat larger tumors.

The LAILT System I, proprietary of LASE MED, Inc. and utilized in the delivery of the L.I.E.S.H. Therapy, is designed to handle any size of tumor.

LMI’s therapy relies on the use of injectable enchancer which is directly injected into the tumor and spreads thorughout it. This OxyM, which is water soluble and completely innocuous, in other words with the same side-effects of a saline solution.

This is an experimental modality that has become a part of “alternative” medical approach. There are no recent publications to suport it and the proprietry system has not been FDA approved, even as a technology. Afsaneh Bakhshandeh, Volker Bath, Gunter J Wiedemann, Walter Longo, Benjamin M Lerner, Cynthia L Tiggelaar, and H Ian Robins Year 2000 guidelines for clinical practice of whole body hyperthermia combined with cytotoxic drugs Journal of Oncology Pharmacy Practice, Vol. 5, No. 3, 131-134 (1999)from the University of Lübeck and the University of Wisconsin

Lagendijk JJ, Van Rhoon GC, Hornsleth SN, Wust P, De Leeuw AC, Schneider CJ, Van Dijk JD, Van Der Zee J, Van Heek-Romanowski R, Rahman SA, Gromoll C.
University Hospital Utrecht, The Netherlands.
ESHO quality assurance guidelines for regional hyperthermiaInt J Hyperthermia. 1998 Mar-Apr;14(2):125-33.

EDTA Chelation – pro

M Levin, MD — Sat, 30 Jun 2012 17:55:52 +0000

EDTA IV chelation is unproven for any indication. Ethylenediaminetetraacetic acid (“EDTA”) is a synthetic amino acid first used in the 1940′s for treatment of heavy metal poisoning. It is widely recognized as effective for that use as well as certain others, including emergency treatment of hypercalcemia and the control of ventricular arrhythmias associated with digitalis toxicity. Proponents claim that EDTA chelation therapy is effective against atherosclerosis and many other serious health problems. Its use is widespread because patients have been led to believe that it is a valid alternative to established medical interventions such as coronary bypass surgery. However, there is no scientific evidence that this is so. It is also used for “lead poisonng” by those who establish this condition by using non-FDA approved testing methods. To my knowledge there iwere two engative studies. In 1992, a group of cardiovascular surgeons in Denmark published results of a double-blinded, randomized, placebo-controlled study of EDTA treatment for severe intermittent claudication A total of 153 patients in two groups received 20 infusions of EDTA or a placebo for 5 to 9 weeks, in a clinical protocol duplicating the conditions used by Olszewer and Carter in 1990. The changes seen in pain-free and maximal walking distances were similar for the EDTA-treated and the placebo group, and there were no long-term therapeutic effects noted in 3-month and 6-month follow-ups. These investigators concluded that chelation was not effective against intermittent claudication. In 2001, researchers at the University of Calgary reported that cardiac patients receiving chelation therapy fared no better than those who received placebo treatment. The patients were randomly assigned to get intravenous infusions twice weekly for 15 weeks and monthly treatments for 12 more weeks. Thirty-nine patients in each group completed the 27-week protocol and were followed for about six more months. The chelation and placebo groups showed no difference in exercise capacity or feelings of well-being, but both groups increased their ability to walk on a treadmill by an average of one minute

Guldager B and others. EDTA treatment of intermittent claudication: A double-blind, placebo-controlled study. Journal of Internal Medicine 231:261-267, 1992.
Knudson ML and others. Chelation therapy for ischemic heart disease: a randomized, controlled trial. JAMA 287:481-486, 2002.
Ernst E. Chelation therapy for coronary heart disease: An overview of all clinical investigations. American Heart Journal 140:139-141, 2000.
Ernst J. Commentary. Chelation therapy does not benefit heart patients. Focus on Alternative and Complementary Therapies 7153, 2002.

Phenylbutyrate – pro

M Levin, MD — Sat, 30 Jun 2012 17:54:35 +0000

Sodium phenylbutyrate is an orphan drug, marketed by Ucyclyd Pharma (Hunt Valley, USA) under the trade name Buphenyl and by Swedish Orphan International (Sweden) as Ammonaps. It, along with special diets, has been used to treat urea cycle disorders. It also has received an orphan drug designation by the FDA for treatment of acute promyelocytic leukemia. It appears to have a number of potentially useful effects. Sodium phenylbutyrate was given an orphan drug designation by the FDA for use as an adjunct to surgery, radiation therapy, and chemotherapy for treatment of patients with primary or recurrent malignant glioma. Orphan drug designation has a lower burden of proof than that required for other FDA approved drugs. It has also been advocated for many years by the Burzynski clinic, more recently in combination with other drugs. Dr. Burzynski is conducting clincal trials with these combinations.

Hogarth P, Lovrecic L, Krainc D. Sodium phenylbutyrate in Huntington’s disease: A dose-finding study. Mov Disord. 2007;22(13):1962-1964.

Fujii T, Yokoyama G, Takahashi H, et al. Preclinical studies of molecular-targeting diagnostic and therapeutic strategies against breast cancer. Breast Cancer. 2008;15(1):73-78.

Dyer, Erica S.; Paulsen, Michelle T.; Markwart, Sonja M.; Goh, Meidee; Livant, Donna L.; Ljungman, Mats (2002).”Phenylbutyrate inhibits the invasive properties of prostate and breast cancer cell lines in the sea urchin embryo basement membrane invasion assay.” International Journal of Cancer 101(5): 496-499.

Luis H. Camacho et al, Phase I dose escalation clinical trial of phenylbutyrate sodium administered twice daily to patients with advanced solid tumors Journal Investigational New Drugs Volume 25, Number 2 / April, 2007 , Pages 131-138

Imetelstat (GRN163L) – pro

M Levin, MD — Sat, 30 Jun 2012 17:51:40 +0000

Imetelstat or GRN163L is a drug that blocks telomerase, and is already in clinical trials as a potential treatment for breast and lung cancer.Imetelstat is a short chain oligonucleotide that binds with high affinity and specificity to the catalytic site of telomerase, resulting in competitive inhibition of enzyme activity or cell death. Imetelstat demonstrated anti-tumor effects in a wide range of preclinical models of hematological and solid tumors. There are six ongoing phase I studies patients with solid tumors, chronic lymphoproliferative disease, multiple myeloma, lung and breast cancers, as a single agent or in combination with standard treatments.

Calin O. Marian, Steve K. Cho, Brian M. Mcellin, Elizabeth A. Maher, Kimmo J. Hatanpaa, Christopher J. Madden, Bruce E. Mickey, Woodring E. Wright, Jerry W. Shay, and Robert M. BachooThe Telomerase Antagonist, Imetelstat, Efficiently Targets Glioblastoma Tumor-Initiating Cells Leading to Decreased Proliferation and Tumor Growth
Clin Cancer Res January 1, 2010 16:154-163; Published OnlineFirst January 4, 2010; doi:10.1158/1078-0432.CCR-09-2850

Small Molecules in Oncology Imetelstat (GRN163L) – Telomerase-Based Cancer Therapy
Volume 184
Springer Berlin Heidelberg
Pages 221-234

Oncosorb, TNF and Dr. Lentz – pro

M Levin, MD — Sat, 30 Jun 2012 17:49:41 +0000

The Oncosorb absorbtion column was invented by Dr. Lentz and described in a monograph, “Unleashing the Immune System: New Insights into Cancer”, Equinox Press, 2010.

The theory behind this treatment is that absorbing out TNF inhibitors will have an “immunostimulating” effect and be beneficial in cancer therapy. There are two isoforms; TNFR-1 (p55) and TNFR-2. TNFR-1 initiates the majority of the biological activities of TNF-α and is expressed on all cell types, whereas TNFR- 2 expression is mainly confined to immune cells. The effects of TNF are both to stimulate and anti-cancer response and to promote cancer development and progression and there have been attempts to exlplain how absorbing out TNF will impact on these two contradictory processes.

While this is an intriguing approach, clinical confirmation is lacking. “Unleashing the Immune System…” cites 15 patients with breat cancer but there is no clinical supporting literature in peer-reviewed literature. Dr. Lentz is “in the process of finishing a series of scientific articles (p. 133)”. He is said to not be “a voluminous writer or voluble speaker. He is fundmantally a man of action”. Neverthelss, he has not produced clinical confirmation of the efficacy of his treatment to the current time. The approach is interesting but confirmation of its efficacy in patients is lacking.

Lentz, Meredith, Kumar, Kiran, Reduction of Plasma Levels of Soluble Tumor Necrosis Factor and Interleukin-2 Receptors by Means of a Novel Immunoadsorption Column, Therapeutic Apheresis and Dialysis, 12:6, 2008

Lentz MR. The role of therapeutic apheresis in the treatment of cancer: a review. Ther Apher 1999;3(1):40-49.

Gatanaga T, Lentz R, Masunaka I, et al. Identification of TNF-LT blocking factor(s) in the serum and ultrafiltrates of human cancer patients. Lymphokine Res. 1990 Summer;9(2):225-9.

Bertazza L, Mocellin S.The dual role of tumor necrosis factor (TNF) in cancer biology.Curr Med Chem. 2010;17(29):3337-3352.

Oral Appliances for Snoring and Obstructive Apnea – pro

M Levin, MD — Wed, 20 Jun 2012 09:17:06 +0000

Obstructive sleep apnea (OSA) is a prevalent disorder, which consists of recurring partial or complete occlusion of the upper airway during sleep, resulting in oxyhemoglobin desaturation and arousal. The associated excessive daytime sleepiness (EDS) and nocturnal symptoms such as snoring, witnessed apneas, and sleep disruption can lead to emotional, marital, social, occupational, and road safety impairment. Oral appliance therapy involves the selection, fitting and use of a specially designed oral appliance that maintains an open, unobstructed airway in the throat when worn during sleep. Custom-made oral appliances are proven to be more effective than over-the-counter devices.

The literature provides evidence for the efficacy of this treatment modality, as well as guidance regarding how to manage side effects and comparison to CPAP and UPPP. It also suggests that this treatment can improve heart burn and acid reflux, depression, and other manifestations of sleep apnea. The guidelines, issued by the American Academy of Sleep Medicine and published in the February 2006 issue of the journal SLEEP, indicate that patients can use oral appliances as therapy for mild to moderate cases of obstructive sleep apnea or when continuous positive airway pressure (CPAP) is not a viable treatment option.

http://www.aasmnet.org/resources/practiceparameters/review_oralapplianceosa.pdf, 2006

http://www.aasmnet.org/Resources/PracticeParameters/PP_Update_OralApplicance.pdf

Thickett EM, Hirani S, Williams A, Hodgkins J. A prospective evaluation assessing the effectiveness of the ‘Dynamax’ mandibular appliance in the management of obstructive sleep apnoea. Surgeon. Feb 2009;7(1):14-7

Ferguson KA, Cartwright R, Rogers R, Schmidt-Nowara W. Oral appliances for snoring and obstructive sleep apnea: a review. Sleep. Feb 1 2006;29(2):244-62