Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Meningioma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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