Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
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 is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer.
|Adenocarcinoma of the Prostate Stage III Prostate Cancer Stage IV Prostate Cancer Recurrent Prostate Cancer||Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Drug: bicalutamide Drug: flutamide Drug: leuprolide acetate Procedure: alternative product therapy Procedure: antiandrogen therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy Procedure: endocrine therapy Procedure: hormone therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 Capsules With Total Androgen Blockade in Patients With Stage III or IV Adenocarcinoma of the Prostate|
- Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor 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 antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy.
Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003517
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|