Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Anaplastic Astrocytoma
- Determine the objective response rate in patients with anaplastic astrocytoma treated
with antineoplastons A10 and AS2-1 after subtotal resection.
- Assess 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
IV 6 times daily until the maximum tolerated dose is reached. Treatment continues for at
least 2 months in the absence of unacceptable toxicity or disease progression. Patients
achieving stable disease or partial response may continue treatment. Patients achieving
complete response (CR) continue treatment for an additional 8 months after CR.
Tumors are measured at 1 month, every 1-2 months for 2 years, every 3 months for the third
year, every 4 months for the fourth year, every 6 months for the fifth year, and then
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response rate assessed by tumor measurements at 12 weeks
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
|Houston, Texas 77055-6330