Phase II Trial With Correlative Laboratory Studies of Single Agent Irinotecan (Camptosar CPT-11) in Newly Diagnosed and Relapsed Indolent Lymphoproliferative Malignancies
OBJECTIVES: I. Determine the complete and partial response rates in patients with newly
diagnosed or relapsed indolent non-Hodgkin's lymphoma, high risk chronic lymphocytic
leukemia, or prolymphocytic leukemia treated with irinotecan. II. Determine the toxicity of
this regimen in these patients. III. Correlate the level of DNA topoisomerase I mRNA and
protein, as well as SN-38 induced topoisomerase I-DNA complex formation, with the clinical
response and toxicity in these patients. IV. Determine if a down regulation of topoisomerase
I or altered subcellular distribution of this enzyme is involved in the drug resistance to
OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Treatment
repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 17-40 patients will be accrued for this study within 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (ORR)
Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Determine the complete and partial response rates in patients with newly diagnosed or relapsed indolent non-Hodgkin's lymphoma, high risk chronic lymphocytic leukemia, or prolymphocytic leukemia treated with irinotecan.
Steven C. Goldstein, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|