Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with incurable anaplastic astrocytoma who experienced disease progression or
recurrence or have residual disease after standard therapy.
- Describe response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose
Treatment continues for at least 3 months in the absence of toxicity and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months during the first year, every 3 months for the second
year, 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.
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|