Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
Recruitment status was: 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 visual pathway glioma.
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 Infusions in Children With Visual Pathway Glioma|
- Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]
- Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
|Study Start Date:||June 1996|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with visual pathway glioma 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 antineoplastons A10 and 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 and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003477
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|