NOTE: The information in this summary is no longer being updated and is provided for reference purposes only.
Antineoplastons are chemical compounds found in urine and blood. They are made up of amino acids (the building blocks of protein) and peptides (compounds made of two or more amino acids). When used in research, antineoplastons are made from chemicals in the laboratory.How are antineoplastons given?
Antineoplastons are given by mouth or by injection (shot).Have any laboratory or animal studies been done using antineoplastons?
In laboratory studies, tumor cells are used to test a substance to find out if it is likely to have any anticancer effects. In animal studies, tests are done to see if a drug, procedure, or treatment is safe and effective in animals. Laboratory and animal studies are done before a substance is tested in people.
Laboratory and animal studies have tested the effects of antineoplastons in laboratory experiments. See the Laboratory/Animal/Preclinical Studies section of the PDQ health professional summary on Antineoplastons for information on laboratory and animal studies done using antineoplastons.Have any studies of antineoplastons been done in people?
No phase III, randomized, controlled trials of antineoplastons as a treatment for cancer have been done. Phase I clinical trials, phase II clinical trials, and case reports have been reported.
Cancer patients have been studied and treated with antineoplastons at the clinic where antineoplastons were first made. A few trials and case studies have been done outside of the clinic. Cancer types studied include breast, bladder, cervical, prostate, liver, lung, brain, leukemia, and lymphoma.
Some patients in the studies received standard treatments and the antineoplastons. In those cases, it is not known if responses and side effects were caused by antineoplaston therapy, the other treatments, or both.
(See the PDQ health professional summary on Antineoplastons for information on clinical trial results.)Have any side effects or risks been reported from antineoplastons?
Side effects from antineoplastons include the following:
The most severe side effects from antineoplastons occurred in a phase II trial in brain tumor patients that included sleepiness, confusion, seizures, and swelling near the brain.Are antineoplastons approved by the U.S. Food and Drug Administration (FDA) for use as a cancer treatment?
Antineoplastons are not approved by the U. S. Food and Drug Administration (FDA) for the prevention or treatment of any disease. The FDA gave the developer permission to run clinical trials of antineoplaston therapy at his own clinic. In the United States, antineoplaston therapy can be obtained only in clinical trials at the developer's clinic.
Use our clinical trial search to find NCI-supported cancer clinical trials that are accepting patients. You can search for trials based on the type of cancer, the age of the patient, and where the trials are being done. General information about clinical trials is also available.
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Purpose of This Summary
This PDQ cancer information summary has current information about the use of antineoplastons in the treatment of people with cancer. It is meant to inform and help patients, families, and caregivers. It does not give formal guidelines or recommendations for making decisions about health care.
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The information in this patient summary was taken from the health professional version, which is reviewed regularly and updated as needed, by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board.
Clinical Trial Information
A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about the effects of a new treatment and how well it works. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become "standard." Patients may want to think about taking part in a clinical trial. Some clinical trials are open only to patients who have not started treatment.
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PDQ® Integrative, Alternative, and Complementary Therapies Editorial Board. PDQ Antineoplastons. Bethesda, MD: National Cancer Institute. Updated <MM/DD/YYYY>. Available at: https://www.cancer.gov/about-cancer/treatment/cam/patient/antineoplastons-pdq. Accessed <MM/DD/YYYY>. [PMID: 26389445]
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Complementary and alternative medicine (CAM)—also called integrative medicine—includes a broad range of healing philosophies, approaches, and therapies. A therapy is generally called complementary when it is used in addition to conventional treatments; it is often called alternative when it is used instead of conventional treatment. (Conventional treatments are those that are widely accepted and practiced by the mainstream medical community.) Depending on how they are used, some therapies can be considered either complementary or alternative. Complementary and alternative therapies are used in an effort to prevent illness, reduce stress, prevent or reduce side effects and symptoms, or control or cure disease.
Unlike conventional treatments for cancer, complementary and alternative therapies are often not covered by insurance companies. Patients should check with their insurance provider to find out about coverage for complementary and alternative therapies.
Cancer patients considering complementary and alternative therapies should discuss this decision with their doctor, nurse, or pharmacist as they would any type of treatment. Some complementary and alternative therapies may affect their standard treatment or may be harmful when used with conventional treatment.
It is important that the same scientific methods used to test conventional therapies are used to test CAM therapies. The National Cancer Institute and the National Center for Complementary and Integrative Health (NCCIH) are sponsoring a number of clinical trials (research studies) at medical centers to test CAM therapies for use in cancer.
Conventional approaches to cancer treatment have generally been studied for safety and effectiveness through a scientific process that includes clinical trials with large numbers of patients. Less is known about the safety and effectiveness of complementary and alternative methods. Few CAM therapies have been tested using demanding scientific methods. A small number of CAM therapies that were thought to be purely alternative approaches are now being used in cancer treatment—not as cures, but as complementary therapies that may help patients feel better and recover faster. One example is acupuncture. According to a panel of experts at a National Institutes of Health (NIH) meeting in November 1997, acupuncture has been found to help control nausea and vomiting caused by chemotherapy and pain related to surgery. However, some approaches, such as the use of laetrile, have been studied and found not to work and to possibly cause harm.
The NCI Best Case Series Program which was started in 1991, is one way CAM approaches that are being used in practice are being studied. The program is overseen by the NCI's Office of Cancer Complementary and Alternative Medicine (OCCAM). Health care professionals who offer alternative cancer therapies submit their patients' medical records and related materials to OCCAM. OCCAM carefully reviews these materials to see if any seem worth further research.
When considering complementary and alternative therapies, patients should ask their health care provider the following questions:
National Center for Complementary and Integrative Health (NCCIH)
The National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH) facilitates research and evaluation of complementary and alternative practices, and provides information about a variety of approaches to health professionals and the public.
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CAM on PubMed
NCCIH and the NIH National Library of Medicine (NLM) jointly developed CAM on PubMed, a free and easy-to-use search tool for finding CAM-related journal citations. As a subset of the NLM's PubMed bibliographic database, CAM on PubMed features more than 230,000 references and abstracts for CAM-related articles from scientific journals. This database also provides links to the websites of over 1,800 journals, allowing users to view full-text articles. (A subscription or other fee may be required to access full-text articles.)
Office of Cancer Complementary and Alternative Medicine
The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) coordinates the activities of the NCI in the area of complementary and alternative medicine (CAM). OCCAM supports CAM cancer research and provides information about cancer-related CAM to health providers and the general public via the NCI website.
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U.S. residents may call the Cancer Information Service (CIS), NCI's contact center, toll free at 1-800-4-CANCER (1-800-422-6237) Monday through Friday from 9:00 am to 9:00 pm. A trained Cancer Information Specialist is available to answer your questions.
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Last Revised: 2019-08-15
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