Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
This trial is active, not recruiting.
|Treatments||antineoplaston a10, antineoplaston as2-1|
|Sponsor||Burzynski Research Institute|
|Start date||August 1998|
|Trial size||40 participants|
|Trial identifier||NCT00003516, BC-PR-5, CDR0000066559|
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.
Male participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically proven stage III or IV adenocarcinoma of the prostate not potentially curable by surgery or radiotherapy - Measurable tumors or tumor markers - No response to antiandrogen withdrawal PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT no greater than 2 times normal - No hepatic failure Renal: - BUN less than 60 mg/dL - Creatinine no greater than 2.5 mg/dL OR - Creatinine clearance greater than 60 mL/min - Blood ammonia normal - No chronic renal failure Cardiovascular: - No severe heart disease Pulmonary: - No severe lung disease Other: - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious active infection or fever - No other concurrent serious disease - No other prior or concurrent malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: - At least 4 weeks since prior hormonal therapy and recovered - Prior corticosteroids for at least 2 months allowed, but must be on stable or decreasing dose during study participation Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 4 weeks since prior surgery and recovered Other: - At least 4 weeks since prior experimental clinical trial - No other concurrent therapy for metastatic disease
|Official title||Phase II Study of Antineoplaston A10 and AS2-1 Capsules In Patients With Incurable, Stage C or D Adenocarcinoma of the Prostate|
|Description||OBJECTIVES: - 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.|
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