Relapsing Chronic Myelogenous Leukemia Clinical Trial
Official title:
A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia
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
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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