Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with
ependymoma by determining the proportion of patients who experience an objective tumor
- Evaluate the adverse side effects and tolerance to 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 12 months in the absence of disease progression and
unacceptable toxicity. After 12 months, patients with stable disease may continue treatment.
Tumors are measured at least every 8 weeks during the first 2 years, every 3 months during
the third and fourth years, every 6 months during the fifth and sixth years, and yearly
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
United States: Federal Government
|Burzynski Clinic||Houston, Texas 77055-6330|