Antineoplastons (PDQ®)–Patient Version
NOTE: The information in this summary is no longer being updated and is provided for reference purposes only.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. Antineoplastons are made in a laboratory when used for research. (See Question 1.)
- No randomized, controlled trials of antineoplastons have been published in peer-reviewed scientific journals. (See Question 4.)
- Clinical trials are being done at the clinic where antineoplastons were first made to study the effect of antineoplastons on cancer. (See Question 4.)
- Antineoplastons have caused mild to severe side effects. (See Question 5.)
- Antineoplastons are not approved by the U. S. Food and Drug Administration for the prevention or treatment of any disease. (See Question 6.)
Questions and Answers About Antineoplastons
- What are antineoplastons?
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:
- Anemia (lower than normal number of red blood cells).
- Abnormal levels of calcium in the blood.
- High blood pressure.
- Irregular heartbeat.
- Fever and chills.
- Nausea and vomiting.
- Dry or itchy skin rash.
- Tiredness or sleepiness.
- Swelling caused by excess fluid in body tissues.
- Swelling, pain, or stiffness in small joints.
- Swelling near the brain.
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.
Current Clinical Trials
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.
About This PDQ Summary
Physician Data Query (PDQ) is the National Cancer Institute's (NCI's) comprehensive cancer information database. The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries come in two versions. The health professional versions have detailed information written in technical language. The patient versions are written in easy-to-understand, nontechnical language. Both versions have cancer information that is accurate and up to date and most versions are also available in Spanish.
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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.
Reviewers and Updates
Editorial Boards write the PDQ cancer information summaries and keep them up to date. These Boards are made up of experts in cancer treatment and other specialties related to cancer. The summaries are reviewed regularly and changes are made when there is new information. The date on each summary ("Updated") is the date of the most recent change.
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.
Clinical trials can be found online at NCI's website. For more information, call the Cancer Information Service (CIS), NCI's contact center, at 1-800-4-CANCER (1-800-422-6237).
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The best way to cite this PDQ summary is:
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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General CAM Information
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.
Evaluation of CAM Therapies
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.
Questions to Ask Your Health Care Provider About CAM
When considering complementary and alternative therapies, patients should ask their health care provider the following questions:
- What side effects can be expected?
- What are the risks related to this therapy?
- What benefits can be expected from this therapy?
- Do the known benefits outweigh the risks?
- Will the therapy affect conventional treatment?
- Is this therapy part of a clinical trial?
- If so, who is the sponsor of the trial?
- Will the therapy be covered by health insurance?
To Learn More About CAM
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.
- NCCIH Clearinghouse
- Post Office Box 7923 Gaithersburg, MD 20898–7923
- Telephone: 1-888-644-6226 (toll free)
- TTY (for deaf and hard of hearing callers): 1-866-464-3615
- E-mail: email@example.com
- Website: https://nccih.nih.gov
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.
National Cancer Institute (NCI) Cancer Information Service
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.
Food and Drug Administration
The Food and Drug Administration (FDA) regulates drugs and medical devices to ensure that they are safe and effective.
- Food and Drug Administration
- 10903 New Hampshire Avenue
- Silver Spring, MD 20993
- Telephone: 1-888-463-6332 (toll free)
- Website: http://www.fda.gov
Federal Trade Commission
The Federal Trade Commission (FTC) enforces consumer protection laws. Publications available from the FTC include:
- Who Cares: Sources of Information About Health Care Products and Services
- Fraudulent Health Claims: Don’t Be Fooled
- Consumer Response Center
- Federal Trade Commission
- 600 Pennsylvania Avenue, NW
- Washington, DC 20580
- Telephone: 1-877-FTC-HELP (1-877-382-4357) (toll free)
- TTY (for deaf and hard of hearing callers): 202-326-2502
- Website: http://www.ftc.gov