Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Meningioma
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with meningioma.
- Describe 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 for at least 3 months in the absence of disease progression. Patients
achieving complete response (CR) continue treatment for an additional 8 months after
reaching CR.
Tumors are measured every 1-3 months during the first 2 years, every 3-4 months during the
third and fourth years, every 4-6 months during the fifth year, and yearly thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Study Chair
Burzynski Research Institute
United States: Federal Government
CDR0000066521
NCT00003483
August 1998
Name | Location |
---|---|
Burzynski Clinic | Houston, Texas 77055-6330 |