Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
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||May 1996|
|End date||December 2011|
|Trial size||40 participants|
|Trial identifier||NCT00003472, BC-BT-17, CDR0000066509|
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 is studying how well antineoplaston therapy works in treating patients with recurrent or refractory oligodendroglioma after previous chemotherapy, radiation therapy, and/or biological therapy.
Response rate based on tumor measurements taken at 12 weeks
Survival at 1, 2, and 5 years from the start of treatment
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy - Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography - Measurable disease by MRI or CT scan - Tumor must be at least 5 mm - Must have received and failed prior standard therapy (i.e., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent) - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 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 severe heart disease - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No serious active infections - No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy Surgery: - Recovered from any prior surgery Other: - No prior antineoplaston therapy
|Official title||Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma|
|Description||OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with recurrent or refractory oligodendroglioma. - 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 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 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, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.|
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