Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors
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 primary malignant brain tumors.
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
primary malignant brain tumors by determining the proportion of patients who experience
an objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these children.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment
continues for at least 12 months in the absence of disease progression or unacceptable
toxicity. After 12 months, patients with responding or stable disease may continue
treatment.
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth
years, every 6 months for the fifth and sixth years, 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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