Last updated on June 2009

Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas


Brief description of study

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 recurrent or refractory mixed gliomas.

Detailed Study Description

OBJECTIVES: - Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable progressive, recurrent, or persistent mixed gliomas following standard therapy. - Assess the response, 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 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of toxicity and disease progression. Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, then annually thereafter. PROJECTED ACCRUAL: This study will accrue 20-40 patients.

Clinical Study Identifier: NCT00003473

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