Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101088
Status:
TERMINATED
Last Update Posted:
2013-01-14
First Post:
2005-01-07
Brief Title:
Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of CCI-779 in Combination With Imatinib Mesylate in Chronic Myelogenous Leukemia
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCI-04-04 | None | None | None |
| R21CA112936 | NIH | None | httpsreporternihgovquickSearchR21CA112936 |