Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
|ClinicalTrials.gov Identifier: NCT00101088|
Recruitment Status : Terminated
First Posted : January 10, 2005
Last Update Posted : January 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|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 Drug: temsirolimus Other: laboratory biomarker analysis||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||June 2010|
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: laboratory biomarker analysis
- Unacceptable toxicity graded according to the NCI CTCAE version 3.0 [ Time Frame: Up to 5 years ]
- Disease progression [ Time Frame: Up to 5 years ]
- Duration of response [ Time Frame: Up to 5 years ]Presented using descriptive statistics.
- Survival [ Time Frame: Up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|