Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Tumors
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening brain tumors.
- Describe response to, 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 2 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR. Patients achieving partial response or stable disease continue
treatment until disease progression.
Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth
years, every 4-6 months for the fifth year, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
Masking: Open Label, Primary Purpose: Treatment
Response rate based on tumor measurements at 12 weeks
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
|Burzynski Clinic||Houston, Texas 77055-6330|