Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
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 studies the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme|
|Study Start Date:||November 1998|
- Determine the objective response rate to escalating doses of antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme.
- Assess tolerance to and side effects of this regimen in these patients.
OUTLINE: 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 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after CR.
Tumors are measured after 1 month, every 1-2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003456
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|