Phase II Trial With Correlative Laboratory Studies of Single Agent Irinotecan (Camptosar CPT-11)

Phase 2

Completed

• Conditions: Leukemia; Lymphoma
• Interventions: Drug: Irinotecan

• Registration Number: NCT00005626
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1998-02
• Study First Submitted: 2000-05-02
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Study First Submitted QC: 2004-08-09
• Study First Posted: 2004-08-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan Treatment	Irinotecan	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	5 years	Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States