Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate
- Determine the antitumor activity of antineoplaston A10 and AS2-1 capsules in patients
with stage III or IV adenocarcinoma of the prostate by determining the proportion of
patients who experience an objective response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
capsules 6 to 7 times a day until the maximum tolerated dose is reached. Treatment continues
for at least 3 months in the absence of disease progression or unacceptable toxicity.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
United States: Federal Government
|Burzynski Clinic||Houston, Texas 77055-6330|