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Questions and Answers About Antineoplastons
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What are antineoplastons?
Antineoplastons are a group of chemical compounds that are found normally in urine and blood. They are made up mostly of amino acids (the building blocks of protein) and peptides (compounds made of two or more amino acids). For use in medical research, antineoplastons were originally taken from human urine, but they are now made from chemicals in the laboratory.
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What is the history of the discovery and use of antineoplastons as a complementary and alternative treatment for cancer?
Antineoplaston therapy was developed by Dr. S. R. Burzynski. He proposed that there must be a process in the body that controls how a cell develops, and that this process fails when a cell divides endlessly and develops into a tumor. He suggested that certain natural substances, which he named "antineoplastons," switch an abnormal cell back onto the path of normal development. Since peptides are considered to be the carriers of instructions in the body, he began looking for peptides that may be present in the blood of cancer patients. After comparing the blood of healthy people to the blood of people with cancer, Dr. Burzynski found that people with cancer have lower amounts of a certain group of chemicals. He found these same chemicals in urine and suggested that some of these chemicals can be used to stop certain cancer cells from dividing.
Dr. Burzynski separated and removed several different types of antineoplastons from the urine of healthy people. He tested these antineoplastons on normal and abnormal cells to see their effect and found that some types of antineoplastons were more effective on more types of abnormal cells than others. He called this type antineoplaston A. He later developed and tested antineoplastons A1, A2, A3, A4, and A5. He found that A2 had the most effect on tumor cells and named the active ingredient in it A10. Other antineoplastons followed. In 1976, Dr. Burzynski proposed the use of antineoplastons as a possible cancer treatment and began treating patients in clinical trials at his own clinic. (See Question 6 1.) Since 1980, Dr. Burzynski has made the antineoplastons from chemicals in his laboratory, instead of taking them from urine or blood.
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What is the theory behind the claim that antineoplastons are useful in treating cancer?
According to Dr. Burzynski, when the body does not have enough antineoplastons, cells that begin to develop abnormally are not corrected, and tumors form and grow. He suggests that antineoplaston therapy supplies the body with the substances needed to correct the abnormal development of the cell and allow it to develop normally or to die a natural cell death, while healthy cells are not affected.
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How are antineoplastons administered?
Antineoplastons have been given in different ways. Today, most antineoplastons are given by mouth or by injection (shot).
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Have any preclinical (laboratory or animal) studies been conducted using antineoplastons?
Research in a laboratory or using animals is done to find out if a drug, procedure, or treatment is likely to be useful in humans. These preclinical studies are done before testing in humans is begun.
Dr. Burzynski did laboratory studies to see how antineoplastons affect human cancer cells. He reported that antineoplaston A killed human cancer cells but had no effect on animal tumor cells. Other types of antineoplastons have not been tested in animals.
Japanese scientists tested some types of antineoplastons on human liver cancer cells. High doses were needed to slow the growth of the cells or cause them to die.
Several laboratory-made antineoplastons have been tested on various types of cells and were reported to be more effective than the natural form taken from urine.
(See the PDQ health professional summary on Antineoplastons 2 for more information on preclinical study results.)
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Have any clinical trials (research studies with people) of antineoplastons been conducted?
To date, no phase III randomized, controlled trials of antineoplastons as a treatment for cancer have been conducted.
Many cancer patients have been treated with antineoplastons at Dr. Burzynski's clinic and studied there. A few trials and case studies have been done outside of the clinic. Some of the cancers studied include breast, bladder, cervical, prostate, liver, and lung cancers, leukemia, lymphoma, and brain tumors.
Published information includes results from phase I clinical trials, phase II clinical trials, and case reports. The following antineoplastons were studied in clinical trials:
- Antineoplaston A
- Antineoplaston A10
- Antineoplaston AS2-1
- Antineoplaston AS2-5
- Antineoplaston A2
- Antineoplaston A3
- Antineoplaston A5
Safety of Antineoplastons
Phase I trials are the first step in testing a new treatment in people. In these studies, researchers test to see what dose is safe, how the treatment should be given (such as by mouth or by injection), and how often it should be given.
In the phase I trials of antineoplastons, side effects were usually mild and did not last long.
The most severe harmful side effects occurred in a phase II trial. Phase II cancer trials study how a treatment works against certain types of cancer and how it affects the body. A phase II trial of antineoplastons A10 and AS2-1 in brain tumor patients reported severe nervous system side effects including sleepiness, confusion, seizures, and swelling near the brain.
(See Question 7 3.)
Effect of Antineoplastons on Brain Tumors, Prostate Cancer, and Liver Cancer
Studies have reported on the effect of antineoplastons in certain types of cancer:
- The effect of antineoplastons A10 and AS2-1 on brain tumors was studied at Dr. Burzynski's clinic and at the Mayo Clinic. A brain tumor study done in Japan did not report the type of antineoplaston used.
- The effect of antineoplaston AS2-1 on prostate cancer was studied at Dr. Burzynski's clinic.
- The effect of antineoplaston A10 on liver cancer is discussed in a case report from Japan.
These studies reported mixed results, including some cancer remissions (signs and symptoms of cancer decreased or went away). Other investigators have not been able to obtain the same results reported by Dr. Burzynski and his team. Some of the patients in the reported studies received standard treatments in addition to the antineoplastons. In those cases, it is not known if responses and side effects were caused by antineoplaston therapy, the other treatments, or both. One additional independent report (a study from Japan) was completed but does not have the same findings as the Burzynski report.
(See the PDQ health professional summary on Antineoplastons 2 for detailed information on clinical trial results.)
Randomized controlled trials give the highest level of evidence. In these trials, volunteers are put randomly (by chance) into one of 2 or more groups that compare different treatments. One group (called the control group) does not receive the new treatment being studied. The control group is compared to the groups that receive the new treatment, to see if the new treatment works. No randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals.
In 1991, the National Cancer Institute (NCI) reviewed some of Dr. Burzynski’s cases and decided to conduct clinical trials on antineoplastons at cancer centers. By August 1995, only 9 patients had enrolled and the clinical trials were closed before being completed.
The U. S. Food and Drug Administration (FDA) gave Dr. Burzynski permission to conduct clinical trials of antineoplaston therapy at his own clinic.
Ongoing non-randomized clinical trials at the Burzynski clinic continue to study the effect of antineoplastons on cancer.
The antineoplastons now used in clinical trials are A10, AS2-5, AS2-1, A2, A3, and A5. Information about ongoing clinical trials is available from the NCI Web site 4.
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Have any side effects or risks been reported from antineoplastons?
Antineoplaston side effects included mild, short-term side effects as well as serious nervous system problems.
The following mild side effects have been noted:
Serious nervous system side effects included the following:
- Extreme sleepiness.
- Confusion.
- Seizures.
- Swelling near the brain.
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Are antineoplastons approved by the U.S. Food and Drug Administration (FDA) for use as a cancer treatment in the United States?
Antineoplastons are not approved by the FDA for the prevention or treatment of any disease. In the United States, antineoplaston therapy can be obtained only in clinical trials at Dr. Burzynski’s clinic.
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Glossary Terms
abnormal
Not normal. An abnormal lesion or growth may be cancer, premalignant (likely to become cancer), or benign (not cancer).
amino acid (uh-MEE-noh A-sid)
One of several molecules that join together to form proteins. There are 20 common amino acids found in proteins.
anemia (a-NEE-mee-a)
A condition in which the number of red blood cells is below normal.
antineoplaston (AN-tee-NEE-oh-PLAS-ton)
A substance isolated from normal human blood and urine that is being tested as a type of treatment for some tumors and AIDS.
bladder cancer (BLA-der KAN-ser)
Cancer that forms in tissues of the bladder (the organ that stores urine). Most bladder cancers are transitional cell carcinomas (cancer that begins in cells that normally make up the inner lining of the bladder). Other types include squamous cell carcinoma (cancer that begins in thin, flat cells) and adenocarcinoma (cancer that begins in cells that make and release mucus and other fluids). The cells that form squamous cell carcinoma and adenocarcinoma develop in the inner lining of the bladder as a result of chronic irritation and inflammation.
blood
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
brain tumor
The growth of abnormal cells in the tissues of the brain. Brain tumors can be benign (not cancer) or malignant (cancer).
breast cancer (brest KAN-ser)
Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.
calcium (KAL-see-um)
A mineral needed for healthy teeth, bones, and other body tissues. It is the most common mineral in the body. A deposit of calcium in body tissues, such as breast tissue, may be a sign of disease.
cancer (KAN-ser)
A term for
diseases in which abnormal cells divide without control and
can invade nearby tissues. Cancer cells can also spread to
other parts of the body through the blood and lymph
systems. There are several main types of cancer. Carcinoma
is cancer that begins in the skin or in tissues that line
or cover internal organs. Sarcoma is cancer that begins in
bone, cartilage, fat, muscle, blood vessels, or other
connective or supportive tissue. Leukemia is cancer that
starts in blood-forming tissue such as the bone marrow, and
causes large numbers of abnormal blood cells to be produced
and enter the blood. Lymphoma and multiple myeloma are
cancers that begin in the cells of the immune system.
Central nervous system cancers are cancers that begin in
the tissues of the brain and spinal cord.
case report
A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin).
cell (sel)
The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.
cervical cancer (SER-vih-kul KAN-ser)
Cancer that forms in tissues of the cervix (the organ connecting the uterus and vagina). It is usually a slow-growing cancer that may not have symptoms but can be found with regular Pap tests (a procedure in which cells are scraped from the cervix and looked at under a microscope).
clinical trial
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.
compound (KOM-pownd)
In science, a substance that is made up of more than one ingredient.
confusion (kun-FYOO-zhun)
A mental state in which one is not thinking clearly.
control group
In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.
controlled clinical trial
A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all.
dose
The amount of medicine taken, or radiation given, at one time.
drug
Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.
fever (FEE-ver)
An increase in body temperature above normal (98.6 degrees F), usually caused by disease.
fluid (FLOO-id)
A substance that flows smoothly and takes the shape of its container. Liquids and gases are fluids.
Food and Drug Administration
An
agency in the U.S. federal government whose mission is to
protect public health by making sure that food, cosmetics,
and nutritional supplements are safe to use and truthfully
labeled. The Food and Drug Administration also makes sure
that drugs, medical devices, and equipment are safe and
effective, and that blood for transfusions and transplant
tissue are safe. Also called FDA.
high blood pressure (hy blud PREH-sher)
A blood pressure of 140/90 or higher. High blood pressure usually has no symptoms. It can harm the arteries and cause an increase in the risk of stroke, heart attack, kidney failure, and blindness. Also called hypertension.
injection
Use of a syringe and needle to push fluids or drugs into the body; often called a "shot."
laboratory study
Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.
leukemia (loo-KEE-mee-uh)
Cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of blood cells to be produced and enter the bloodstream.
liver cancer
Primary liver cancer is cancer that forms in the tissues of the liver. Secondary liver cancer is cancer that spreads to the liver from another part of the body.
lung cancer (lung KAN-ser)
Cancer that forms in tissues of the lung, usually in the cells lining air passages. The two main types are small cell lung cancer and non-small cell lung cancer. These types are diagnosed based on how the cells look under a microscope.
lymphoma (lim-FOH-muh)
Cancer that begins in cells of the immune system. There are two basic categories of lymphomas. One kind is Hodgkin lymphoma, which is marked by the presence of a type of cell called the Reed-Sternberg cell. The other category is non-Hodgkin lymphomas, which includes a large, diverse group of cancers of immune system cells. Non-Hodgkin lymphomas can be further divided into cancers that have an indolent (slow-growing) course and those that have an aggressive (fast-growing) course. These subtypes behave and respond to treatment differently. Both Hodgkin and non-Hodgkin lymphomas can occur in children and adults, and prognosis and treatment depend on the stage and the type of cancer.
National Cancer Institute
The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.
nausea
A feeling of sickness or discomfort in the stomach that may come with an urge to vomit. Nausea is a side effect of some types of cancer therapy.
nervous system (NER-vus SIS-tem)
The organized network of nerve tissue in the body. It includes the central nervous system (the brain and spinal cord), the peripheral nervous system (nerves that extend from the spinal cord to the rest of the body), and other nerve tissue.
PDQ
PDQ is an online database developed and maintained by the National Cancer Institute. Designed to make the most current, credible, and accurate cancer information available to health professionals and the public, PDQ contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, complementary and alternative medicine, and supportive care; a registry of cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care. Most of this information, and more specific information about PDQ, can be found on the NCI's Web site at http://www.cancer.gov/cancertopics/pdq. Also called Physician Data Query.
peer-reviewed scientific journal
A publication that contains original articles that have been written by scientists and evaluated for technical and scientific quality and correctness by other experts in the same field.
peptide (PEP-tide)
A molecule that contains two or more amino acids (the molecules that join together to form proteins). Peptides that contain many amino acids are called polypeptides or proteins.
phase I trial
The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.
phase II trial
A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.
phase III trial
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
preclinical study
Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.
prevention (pree-VEN-shun)
In medicine, action taken to decrease the chance of getting a disease or condition. For example, cancer prevention includes avoiding risk factors (such as smoking, obesity, lack of exercise, and radiation exposure) and increasing protective factors (such as getting regular physical activity, staying at a healthy weight, and having a healthy diet).
prostate cancer (PROS-tayt KAN-ser)
Cancer that forms in tissues of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum). Prostate cancer usually occurs in older men.
protein (PRO-teen)
A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.
randomized clinical trial
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
red blood cell
A cell that carries oxygen to all parts of the body. Also called erythrocyte and RBC.
remission
A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body.
response (reh-SPONTS)
In medicine, an improvement related to treatment.
seizure (SEE-zhur)
Convulsion; a sudden, involuntary movement of the muscles.
side effect
A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.
standard therapy (...THAYR-uh-pee)
In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.
symptom
An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.
therapy (THAYR-uh-pee)
Treatment.
tissue (TISH-oo)
A group or layer of cells that work together to perform a specific function.
tumor (TOO-mer)
An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancer), or malignant (cancer). Also called neoplasm.
urine (YOOR-in)
Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra.
vomit
To eject some or all of the contents of the stomach through the mouth.
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Table of Links
1 | http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/15.cdr#Secti on_15 |
2 | http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional |
3 | http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/17.cdr#Secti on_17 |
4 | http://cancer.gov/clinicaltrials |
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