Spots Global Cancer Trial Database for Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

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Trial Identification

Brief Title: Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

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

Study ID: NCT00003517

Conditions

Adenocarcinoma of the Prostate

Stage III Prostate Cancer

Stage IV Prostate Cancer

Recurrent Prostate Cancer

Interventions

alternative product therapy

antiandrogen therapy

biological therapy

biologically based therapies

cancer prevention intervention

complementary and alternative therapy

differentiation therapy

endocrine therapy

hormone therapy

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.