RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have newly diagnosed or relapsed non-Hodgkin's lymphoma or leukemia.
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 irinotecan. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Irinotecan as outlined in treatment arm
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
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.
Time frame: 5 years
Number of Participants with Adverse Events
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Time frame: 5 years
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