Antineoplastons (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - History
As noted in the General Information section, Burzynski first proposed antineoplastons as a naturally occurring biochemical defense against cancer in 1976 as a result of his study of cybernetic systems and information theory. The search for information-bearing peptides in body fluids led him to separate peptides from human blood and subsequently from human urine. He called these substances antineoplastons and categorized them according to their general and specific anticarcinogenic potential. In 1980, the developer characterized the chemical structures of antineoplastons and began preparing them synthetically rather than isolating them from human urine. Preparations now used in clinical studies to treat cancer are antineoplastons A10, AS2-5, AS2-1, A2, A3, and A5.
From 1991 to 1995, the National Cancer Institute (NCI) initiated phase II clinical trials of antineoplastons A10 and AS2-1. Protocols for two phase II clinical trials were originally developed by investigators from several cancer centers, with review and input from both the developer and NCI. The National Institutes of Health, Office of Alternative Medicine, now known as the National Center for Complementary and Alternative Medicine, provided funding for the trials. Three centers (Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at NIH) began accruing participants for these NCI-sponsored studies in 1993. However, by August 1995 only nine patients had entered the trials; despite efforts by the developer, NCI staff, and investigators to reach agreement on proposed changes to increase patient accrual and dose, the studies were closed prematurely in August 1995.[1,2]
Endometrial cancer is a disease that primarily affects postmenopausal women at an average age of 60 years at diagnosis. Risk factors include postmenopausal estrogen therapy, obesity, a high-fat diet, reproductive factors like nulliparity, early menarche and late menopause, polycystic ovarian syndrome, and tamoxifen use. Women with hereditary nonpolyposis colorectal cancer syndrome have a markedly increased risk of endometrial cancer compared with women in the general population.
The developer and investigators in Japan have reported several case series showing varying results using antineoplastons as a clinical therapy against several different types of cancer, alone or in combination with standard chemotherapy.[3,4,5,6,7,8,9,10,11,12,13,14] These studies are described in more detail in the Human/Clinical Studies section of this summary. Most of these studies were phase I trials or their equivalent; therefore, the only objective of these trials was safety.