Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
This trial is active, not recruiting.
|Condition||brain and central nervous system tumors|
|Treatments||antineoplaston a10, antineoplaston as2-1|
|Sponsor||Burzynski Research Institute|
|Start date||November 1998|
|Trial identifier||NCT00003456, BRI-BT-7, CDR0000066488|
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 glioblastoma multiforme.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed glioblastoma multiforme - Tumor subtotally resected or biopsied - Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography - No brain stem tumor PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 4 months Hematopoietic: - WBC at least 1,500/mm^3 - Platelet count at least 50,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - No hepatic failure - 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 would contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension Other: - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy - No concurrent immunomodulatory agents Chemotherapy: - No prior chemotherapy - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids for cerebral edema allowed Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics - Recovered from any prior surgery
|Official title||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme|
|Description||OBJECTIVES: - Determine the objective response rate to escalating doses of antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme. - Assess tolerance to and side effects of this regimen in these patients. OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 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 CR. Tumors are measured after 1 month, every 1-2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: Not specified|
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