Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma
OBJECTIVES:
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate based on tumor measurements taken at 12 weeks
No
Stanislaw R. Burzynski, MD, PhD
Study Chair
Burzynski Research Institute
Unspecified
CDR0000066510
NCT00003473
March 1996
Name | Location |
---|---|
Burzynski Clinic | Houston, Texas 77055-6330 |