Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma
- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients
with incurable progressive, recurrent, or persistent mixed gliomas following standard
- 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
PROJECTED ACCRUAL: This study will accrue 20-40 patients.
Masking: Open Label, Primary Purpose: Treatment
Response rate based on tumor measurements taken at 12 weeks
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
|Burzynski Clinic||Houston, Texas 77055-6330|