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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 17 open clinical trials on Antineoplastons (as of January 2008). All of the clinical trials are supervised and monitored by the Food and Drug Administration (FDA).
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Clinical trials conducted in our Clinic are governed by FDA monitored 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 wide range of cancer types 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.
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) and Cancer.gov (NCI database of clinical trials). 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 II clinical trial - Brainstem Glioma
In January 2007, Phase II trial on Brainstem Glioma was officially closed for enrollment. The results of the trial will be submitted for the FDA evaluation once the patients currently in the study complete the treatment.
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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