NCT00101088

Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of temsirolimus when given with imatinib mesylate in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus with imatinib mesylate may kill more cancer cells

Detailed description

OBJECTIVES: I. Determine the safety and tolerability of temsirolimus when administered with imatinib mesylate in patients with chronic myelogenous leukemia. II. Determine potential dose-limiting toxic effects of this regimen in these patients. III. Determine, preliminarily, hematologic and cytogenetic response rates in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of temsirolimus. Patients receive temsirolimus intravenously (IV) over 30 minutes once on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients receive 2 additional courses beyond maximal response. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for survival.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Blastic Phase Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase Chronic Myelogenous Leukemia
• Relapsing Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
DRUG	temsirolimus	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-04-01
• Primary completion: 2010-06-01
• First posted: 2005-01-10
• Last updated: 2013-01-14

Locations

1 site across 1 country: United States