Clinical Trial: Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma
Brief Summary:
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 recurrent or refractory high grade glioma.
Detailed Summary:
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with high-grade 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 antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of unacceptable toxicity or disease progression. After 12 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.
Sponsor: Burzynski Research Institute
Current Primary Outcome: Response rate based on tumor measurements at 12 weeks
Original Primary Outcome:
Current Secondary Outcome: Survival at 1, 2, and 5 years from the start of treatment
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 1, 1999
Date Started: August 1993
Date Completion:
Last Updated: July 14, 2009
Last Verified: June 2009
