Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma
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
children with visual pathway glioma.
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
visual pathway glioma by determining the proportion of patients who experience an
objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open label study.
Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6
times per day until the maximum tolerated dose is reached. Treatment continues for at least
12 months in the absence of disease progression and unacceptable toxicity. After 12 months,
patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third
and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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