Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
Recruitment status was: Active, not recruiting
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||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme|
|Study Start Date:||August 1998|
- Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable glioblastoma multiforme.
- Describe response, 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 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression.
Tumors are measured every 2 months during the first year and every 3 months during the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003474
|United States, Texas|
|Burzynski Research Institute|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|