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| Clinical trials (also clinical research, clinical studies) are research studies to determine whether experimental treatments, or new ways of using known therapies, are safe and effective. Carefully conducted clinical trials are necessary to find treatments that work in people and ways to improve health. |
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| There are four phases of clinical trials in cancer treatment: |
| Phase I trials |
- to determine the safety of a new treatment |
| Phase II trials |
- to determine whether a certain kind of cancer responds to a new treatment |
| Phase III trials |
- to verify whether a new treatment is better than standard treatment |
| Phase IV trials |
- to find more specific information about a new treatment that has been already approved for use in patients |
| Read more |
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Antineoplaston treatment is an experimental therapy offered by the Burzynski Clinic, currently available only within clinical trials.
Read about Antineoplaston Therapy
Currently, there are 12 open clinical trials on Antineoplastons (as of November 2009). All of the clinical trials are registred with the FDA and result of the trials are reported to the FDA on an annual basis.
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Clinical trials conducted in our Clinic are FDA approved protocols. A protocol determines what will be done in a clinical trial and why. It outlines how many patients will participate in a clinical trial, type and frequency of medical testing, treatment plan, monitoring requirements and the evaluation plan. Our staff physicians follow strictly the protocol and submit periodical reports on the progress of the study for FDA evaluation.
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The clinical trials encompass a variety of brain tumors in both children and adults. Over the last ten years more than 2000 patients have participated in the clinical trials on Antineoplastons. Only patients eligible to enroll in clinical trials may receive Antineoplaston treatment under study. Ineligible patients may receive approval to enroll, from the FDA on an individual basis.
To find out if you qualify for enrollment in clinical trials, please contact our Cancer Information Specialist.
The list of open clinical trials is available at: Clinicaltrials.gov (FDA official clinical trials data bank) Please keep in mind that these websites are updated with a certain delay (up to 6 months). For the most recent information please contact the Burzynski Clinic directly.
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The official reports on the progress of the clinical trials on Antineoplastons are presented regularly by Dr. Burzynski and his associates at various medical symposia and conferences. Mid-term reports from the clinical research are regularly published in peer-reviewed journals and subject-related scientific books.
View the most recent scientific publications.
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Clinical Trials: Antineoplastons in Treatment of Brainstem Glioma
Orphan Drug designation
In September 2004, the FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of Brainstem Glioma.
The FDA's orphan drug program is intended to encourage research, development and approval of products for treatment of diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.
Orphan drug designation enables the Burzynski Research Institute to apply for assistance from the Office of Orphan Product Development in guiding the drug through the regulatory approval process.
Phase III clinical trial - Brainstem Glioma
The protocol for the Phase III trials has been submitted for the FDA evaluation. The protocol is currently subject to the FDA revision. Phase III trials are expected to start as soon as the FDA approves the protocol.
Last Update: 07 March 2008
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