Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00003516


Primary Contact:

Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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