Antineoplaston Therapy in Treating Patients With Refractory 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||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.
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
|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.|
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