Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
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 is studying how well antineoplaston therapy works in treating children with rhabdoid tumor of the central nervous system.
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 in Children With Rhabdoid Tumor of the Central Nervous System|
- Response rate based on tumor measurements taken at 12 weeks
- Survival at 1, 2, and 5 years from the start of treatment
|Study Start Date:||February 1996|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with rhabdoid tumor of the central nervous system by determining the proportion of patients who experience an objective tumor response.
- Evaluate the adverse effects of and tolerance to 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 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003469
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|