Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate
- Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable,
metastatic, hormone-refractory adenocarcinoma of the prostate.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 IV and antineoplaston
AS2-1 IV 6 times daily until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease
progression. Patients with partial response or stable disease may continue treatment.
Patients achieving complete response (CR) continue treatment for an additional 8 months
after reaching CR.
Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
United States: Federal Government
|Burzynski Clinic||Houston, Texas 77055-6330|