Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma
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 anaplastic astrocytoma that has not responded to previous treatment.
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with incurable anaplastic astrocytoma who experienced disease progression or
recurrence or have residual disease after standard therapy.
- Describe response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: 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 toxicity and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months during the first year, every 3 months for the second
year, 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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