Spots Global Cancer Trial Database for Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

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Trial Identification

Brief Title: Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma

Study ID: NCT00003505

Conditions

Primary Central Nervous System Lymphoma

Interventions

antineoplaston A10

antineoplaston AS2-1

alternative product therapy

biological therapy

biologically based therapies

cancer prevention intervention

complementary and alternative therapy

differentiation therapy

Study Description

Brief Summary: 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.

Detailed Description: 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.