Temsirolimus and Imatinib Mesylate in Treating Patients With 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
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
Drug: imatinib mesylate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia|
- Unacceptable toxicity graded according to the NCI CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Disease progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Presented using descriptive statistics.
- Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (imatinib mesylate, temsirolimus)
Patients receive temsirolimus 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
Drug: imatinib mesylate
Other Names:Drug: temsirolimus
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101088
|United States, California|
|University of California Medical Center At Irvine-Orange Campus|
|Orange, California, United States, 92868|
|Principal Investigator:||Tiong Ong||University of California Medical Center At Irvine-Orange Campus|