Introduction to Clinical Trials

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.

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

Antineoplastons - Subject of Clinical Trials

Antineoplaston treatment is an experimental therapy offered by the Burzynski Clinic, currently available only within clinical trials.

Currently, there is 1 open clinical trial on Antineoplastons (as of January 2012). The clinical trial is registered with the FDA and result of the trial is reported to the FDA on an annual basis.

• Read more about Antineoplaston Therapy

Quality Control

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 strictly follow the protocol and submit periodical reports on the progress of the study for FDA evaluation.

Enrollment in Clinical Trials

The clinical trials encompass a variety of brain tumors in both children and adults. Over the last ten years more than 2,000 patients have participated in the clinical trials on Antineoplastons. Only patients eligible to enroll in clinical trials may receive Antineoplaston treatment under the 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 (the FDA official clinical trials data bank). For the most recent information please contact the Burzynski Clinic directly.

Reports/Statistics

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.

Latest Developments

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 Orphan Drug designation has been extended to all Gliomas

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 is ready. Phase III trials are expected to start in 2012.

Last Update: January 2012