Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
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 patients with recurrent or refractory mixed gliomas.
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 Adult Patients With Mixed 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:||March 1996|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable progressive, recurrent, or persistent mixed gliomas following standard therapy.
- Assess the response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of toxicity and disease progression.
Tumors are measured every 2 months for 1 year, every 3 months for the second year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year, then annually thereafter.
PROJECTED ACCRUAL: This study will accrue 20-40 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003473
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 firstname.lastname@example.org|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|