Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors
- Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with
primitive neuroectodermal tumors by determining the proportion of patients who
experience an objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times a day until the maximum tolerated dose is reached. Treatment
continues for at least 2 months in the absence of disease progression or unacceptable
toxicity. After 2 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth
years, every 6 months for the fifth and sixth years, and then annually thereafter.
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
United States: Federal Government
|Burzynski Clinic||Houston, Texas 77055-6330|