Antineoplaston Therapy in Treating Patients With Meningioma
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||August 1998|
|Trial size||40 participants|
|Trial identifier||NCT00003483, BC-BT-28, CDR0000066521|
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 meningioma that has progressed or recurred after surgery and radiation therapy.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed incurable meningioma that has progressed or recurred following surgical resection and radiotherapy - Evidence of tumor by MRI or CT scan 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/mm3 - Platelet count at least 50,000/mm3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No 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 chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study - No active infection - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulatory agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed - At least 4 weeks since prior therapy with mifepristone and recovered Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agent allowed - No prior antineoplaston therapy
|Official title||Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Meningioma|
|Description||OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with meningioma. - Describe response, 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 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 1-3 months during the first 2 years, every 3-4 months during the third and fourth years, every 4-6 months during the fifth year, and yearly thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.|
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