Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
Recruitment status was: Active, not recruiting
RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have stage III or stage IV prostate cancer.
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate|
|Study Start Date:||August 1998|
- 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 annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003516
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|