Antineoplaston Therapy in Treating Patients With Metastatic 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||NCT00003533, BC-PR-4, CDR0000066580|
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 metastatic prostate cancer that has not responded to hormone therapy.
Male participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically proven incurable, metastatic, hormone-refractory adenocarcinoma of the prostate that is unlikely to respond to existing therapy - Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan - Stage D2 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 2,000/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 - 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: - At least 4 weeks since prior hormonal therapy (unless progression documented upon discontinuation of hormones) - Concurrent corticosteroids allowed, if stable or decreasing for at least 2 months before study entry Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agent allowed
|Official title||Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Adenocarcinoma of the Prostate|
|Description||OBJECTIVES: - Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable, metastatic, hormone-refractory adenocarcinoma of the prostate. - Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplaston A10 IV and antineoplaston AS2-1 IV 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 with partial response or stable disease may continue treatment. 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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