Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
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|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 Names:Drug: temsirolimus
Other Names: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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|