Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade
- Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients
with serious or immediately life-threatening recurrent or refractory high-grade
- Describe response to, 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
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 or
unacceptable toxicity. After 12 months, patients with responding or stable disease may
Tumors are measured at least every 8 weeks for 6 months, every 3 months for 1.5 years, every
6 months for 2 years, and then annually for 2 years.
Patients are followed for survival.
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|