Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064285
Status:
COMPLETED
Last Update Posted:
2010-05-03
First Post:
2003-07-08
Brief Title:
Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Study Of Flavopiridol In Combination With Imatinib Mesylate STI571 Gleevec In BcrAbl Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 flavopiridol use different ways to stop cancer cells from dividing so they stop growing or die Combining imatinib mesylate with flavopiridol may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of flavopiridol and imatinib mesylate in treating patients with hematologic cancer
PURPOSE This phase I trial is studying the side effects and best dose of flavopiridol and imatinib mesylate in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of flavopiridol and imatinib mesylate in patients with BcrAbl hematological malignancies
Determine the toxic effects of this regimen in these patients
Determine the disease-related effects of this regimen in these patients
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
Correlate response to this regimen with mechanisms of imatinib mesylate resistance in patients previously treated with imatinib mesylate
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to percentage of blasts in the peripheral blood and bone marrow less than 15 vs at least 15 and recent myelosupressive treatment no vs yes
Patients receive oral imatinib mesylate daily and flavopiridol IV over 1 hour on days 2 9 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and flavopiridol 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
PROJECTED ACCRUAL A total of 6-80 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose and recommended phase II dose of flavopiridol and imatinib mesylate in patients with BcrAbl hematological malignancies
Determine the toxic effects of this regimen in these patients
Determine the disease-related effects of this regimen in these patients
Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
Correlate response to this regimen with mechanisms of imatinib mesylate resistance in patients previously treated with imatinib mesylate
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to percentage of blasts in the peripheral blood and bone marrow less than 15 vs at least 15 and recent myelosupressive treatment no vs yes
Patients receive oral imatinib mesylate daily and flavopiridol IV over 1 hour on days 2 9 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and flavopiridol 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
PROJECTED ACCRUAL A total of 6-80 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| U01CA062502 | NIH | None | None |
| MCV-NCI-6013 | None | None | None |
| MCV-VCU-1902 | None | None | None |
| NCI-6013 | None | None | None |
| CWRU-030323 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062502 |