Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in 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 residual or recurrent anaplastic astrocytoma.
OBJECTIVES:
- Determine the objective response rate in patients with anaplastic astrocytoma treated
with antineoplastons A10 and AS2-1 after subtotal resection.
- Assess 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
IV 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 stable disease or partial response may continue treatment. Patients achieving
complete response (CR) continue treatment for an additional 8 months after CR.
Tumors are measured at 1 month, every 1-2 months for 2 years, every 3 months for the third
year, every 4 months for the fourth year, every 6 months for the fifth year, and then
annually 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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