Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening stage II, III, or IV mantle cell
lymphoma.
- Evaluate the 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
intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues
in the absence of disease progression or unacceptable toxicity.
Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months
for the third and fourth years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Stanislaw R. Burzynski, MD, PhD
Study Chair
Burzynski Research Institute
United States: Federal Government
CDR0000066542
NCT00003502
Name | Location |
---|---|
Burzynski Clinic | Houston, Texas 77055-6330 |