Antineoplaston
Encyclopedia
Antineoplaston a word derived from neoplasm, is a name coined by Stanislaw Burzynski
for a group of peptides, derivatives, and mixtures that he uses as an alternative cancer treatment. These compounds are not licensed as drugs but are instead sold and administered by Burzynski as part of clinical trials that he runs at his own establishments, the Burzynski Clinic and the Burzynski Research Institute in Houston, Texas. The clinical efficacy
of antineoplastons combinations for various diseases has been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. Oncologists have described these studies as flawed, with one doctor stating that they are "scientific nonsense". In particular, independent scientists have been unable to reproduce
the positive results reported in Burzynski's studies.
There is no convincing evidence from randomized controlled trial
s that antineoplastons are useful treatments of cancer. The U.S. Food and Drug Administration (FDA) has not approved antineoplastons for the treatment of any disease. The American Cancer Society
has found no evidence that antineoplastons have any beneficial effects in cancer, and it has recommended that people do not spend money on antineoplaston treatments. A 2004 medical review described this treatment as a "disproven therapy".
The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1, a 4:1 mixture of phenylacetic acid
and phenylacetylglutamine
, was derived. The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.
Since antineoplastons are not licensed as treatments for any disease, Burzynski can only sell his products as part of clinical trials. Patients receiving cancer treatment with antineoplastons must therefore first qualify for one of the currently available clinical trials. In order to qualify for most of the trials, a patient must have first failed standard treatment for the condition being treated, or it must be a condition that is unlikely to respond to currently available therapy and for which no curative therapy exists.
Treatment with antineoplastons can be very costly to patients without insurance coverage, exceeding $100,000 for the first year of intravenous treatment. Many insurance companies consider antineoplaston therapy to be investigational and unproven and do not cover the cost.
the benefit reported by Burzynski. A 1999 trial of antineoplastons for malignant glioma found no evidence of tumor responses or efficacy, and was halted because of poor patient accrual. Burzynski registered various Phase II
clinical trials to evaluate antineoplastons. These trials were to be initiated between 1993 and 1998 with an estimated completion date by the end of December 2011.
Stanislaw Burzynski
Stanislaw Rajmund Burzynski is a biochemist and a physician. He is founder, president and chairman of Burzynski Research Institute Inc. , based in Houston and Stafford, Texas...
for a group of peptides, derivatives, and mixtures that he uses as an alternative cancer treatment. These compounds are not licensed as drugs but are instead sold and administered by Burzynski as part of clinical trials that he runs at his own establishments, the Burzynski Clinic and the Burzynski Research Institute in Houston, Texas. The clinical efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
of antineoplastons combinations for various diseases has been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. Oncologists have described these studies as flawed, with one doctor stating that they are "scientific nonsense". In particular, independent scientists have been unable to reproduce
Reproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...
the positive results reported in Burzynski's studies.
There is no convincing evidence from randomized controlled trial
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
s that antineoplastons are useful treatments of cancer. The U.S. Food and Drug Administration (FDA) has not approved antineoplastons for the treatment of any disease. The American Cancer Society
American Cancer Society
The American Cancer Society is the "nationwide community-based voluntary health organization" dedicated, in their own words, "to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and...
has found no evidence that antineoplastons have any beneficial effects in cancer, and it has recommended that people do not spend money on antineoplaston treatments. A 2004 medical review described this treatment as a "disproven therapy".
Background
Stanislaw Burzynski stated that he began investigating the use of antineoplastons after detecting what he considered significant differences in peptides between the blood of cancer patients and a control group. Burzynski first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, in 1970 Burzynski initially purified urine as a bulk source of antineoplastons. Since 1980, he has been using synthetic versions of these compounds.The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1, a 4:1 mixture of phenylacetic acid
Phenylacetic acid
Phenylacetic acid is an organic compound containing a phenyl functional group and a carboxylic acid functional group. It is a white solid with a disagreeable odor...
and phenylacetylglutamine
Phenylacetylglutamine
Phenylacetylglutamine is a product formed by the conjugation of phenylacetate and glutamine. It is a common metabolite that can be found in human urine....
, was derived. The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.
Treatment
Treatment is offered by Burzynski only at the Burzynski Clinic in West Houston, Texas.Since antineoplastons are not licensed as treatments for any disease, Burzynski can only sell his products as part of clinical trials. Patients receiving cancer treatment with antineoplastons must therefore first qualify for one of the currently available clinical trials. In order to qualify for most of the trials, a patient must have first failed standard treatment for the condition being treated, or it must be a condition that is unlikely to respond to currently available therapy and for which no curative therapy exists.
Treatment with antineoplastons can be very costly to patients without insurance coverage, exceeding $100,000 for the first year of intravenous treatment. Many insurance companies consider antineoplaston therapy to be investigational and unproven and do not cover the cost.
Clinical Trials
Burzynski has published several trials claiming effectiveness for antineoplastons, although reviewers have criticized these trials as being "of a rather unclear design". Independent researchers have failed to reproduceReproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...
the benefit reported by Burzynski. A 1999 trial of antineoplastons for malignant glioma found no evidence of tumor responses or efficacy, and was halted because of poor patient accrual. Burzynski registered various Phase II
Phase II
Phase II may refer to:* Phase II clinical trial* Drug metabolism Phase II* Star Trek: Phase II, a planned Star Trek television series that eventually evolved into Star Trek: The Motion Picture...
clinical trials to evaluate antineoplastons. These trials were to be initiated between 1993 and 1998 with an estimated completion date by the end of December 2011.
External links
- US National Cancer Institute Antineoplaston information
- Publications by Stanislaw R. Burzynski