This trial is active, not recruiting.

Condition prostate cancer
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date August 1998
Trial size 40 participants
Trial identifier NCT00003534, BC-PR-8, CDR0000066581


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 refractory stage IV prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed incurable stage IV adenocarcinoma of the prostate that failed to respond to treatment with antineoplaston A10 and AS2-1 capsules and for which no curative therapy exists - Evidence of tumor by MRI or CT scan - No prostate-specific antigen (PSA) response to antiandrogen withdrawal - If PSA changes used to indicate progressive disease, then PSA must increase more than 50% on two determinations at least 2 weeks apart PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - Hemoglobin at least 9 g/dL - WBC at least 2000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - No hepatic insufficiency - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No known chronic heart failure - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as severe chronic obstructive pulmonary disease Other: - Fertile patients must use effective contraception during and for 4 weeks after study participation - Not a high medical or psychiatric risk - No concurrent nonmalignant systemic disease that would preclude therapy - No active infection 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: - See Disease Characteristics - At least 4 weeks since prior hormonal therapy and recovered - Concurrent corticosteroids allowed if dose is stable or decreasing Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agents allowed

Additional Information

Official title Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate
Description OBJECTIVES: - Provide treatment with intravenous antineoplastons A10 and AS2-1 for patients with incurable adenocarcinoma of the prostate who failed to respond to treatment with antineoplaston A10 and AS2-1 capsules. - Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually increasing doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).