Adenocarcinoma of the Prostate Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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