Primary Central Nervous System Lymphoma Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma
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 primary central nervous system lymphoma.
OBJECTIVES:
- Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening primary central nervous system
lymphoma.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston 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 or unacceptable
toxicity. After 12 months, patients with responding or stable disease may continue
treatment.
Tumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months
for years 3 and 4, and then annually for years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
;
Primary Purpose: Treatment
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