Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066326
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2003-08-06
Brief Title:
Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study Of The Combination Of 17-AAG And Imatinib Mesylate Gleevec In Patients With Blastic Phase Accelerated Phase Of Chronic Mesylate Leukemia CML Or Patients With Chronic Phase CML Who Have Not Achieved A Cytogenetic Response With Imatinib Mesylate
Status:
COMPLETED
Status Verified Date:
2013-04
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:
RATIONALE Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from dividing so they stop growing or die Combining imatinib mesylate with chemotherapy may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in treating patients with chronic myelogenous leukemia
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in treating patients with chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG when administered with imatinib mesylate in patients with chronic myelogenous leukemia
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is an open-label nonrandomized multicenter dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG
Patients receive oral imatinib mesylate on days 1-21 and 17-AAG IV over 1 hour on days 1 4 8 and 12 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-AAG 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 Once the MTD is determined an additional cohort of 6-10 patients receives treatment at the recommended phase II dose
PROJECTED ACCRUAL Approximately 21-42 patients will be accrued for this study within 15 years
Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG when administered with imatinib mesylate in patients with chronic myelogenous leukemia
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is an open-label nonrandomized multicenter dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG
Patients receive oral imatinib mesylate on days 1-21 and 17-AAG IV over 1 hour on days 1 4 8 and 12 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-AAG 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 Once the MTD is determined an additional cohort of 6-10 patients receives treatment at the recommended phase II dose
PROJECTED ACCRUAL Approximately 21-42 patients will be accrued for this study within 15 years
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 |
|---|---|---|---|
| U01CA062487 | NIH | None | None |
| P30CA022453 | NIH | None | None |
| WSU-C-2599 | None | None | None |
| NCI-5932 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |