Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015847
Status:
TERMINATED
Last Update Posted:
2012-08-20
First Post:
2001-05-06
Brief Title:
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase III Dose-Finding Study to Determine the Safety Tolerability and Anti-Leukemic Effects of STI571 NSC 716051 in Combination With Interferon-alpha in Patients With Chronic Myelogenous Leukemia in Chronic Phase
Status:
TERMINATED
Status Verified Date:
2012-06
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 and interferon alfa may interfere with the growth of the cancer cells Combining imatinib mesylate with interferon alfa may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of interferon alfa administered with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia Phase I closed to accrual as of 7903
Determine the safety and tolerability of this regimen in this patient population
Determine the complete major and minor cytogenetic response rates and complete hematologic response rate in patients after 6 and 12 months of treatment with this regimen
Determine the molecular response reverse transcriptase-polymerase chain reaction for bcr-abl rate in patients who have a complete cytogenetic response after 6 and 12 months of treatment with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Phase I closed to accrual as of 7903 Patients receive oral imatinib mesylate once daily beginning on day 1 and interferon alfa IFN-A subcutaneously once daily or 3 times weekly beginning on day 14 Courses repeat every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity After completion of 1 year of therapy patients may receive additional therapy provided that the patient is benefiting from imatinib mesylate IFN-A is discontinued in patients who achieve a molecular remission that is confirmed on 2 successive bone marrow samples Imatinib mesylate is discontinued in patients who achieve and maintain a molecular remission for 2 years
Sequential dose escalation of IFN-A is followed by sequential dose escalation of imatinib mesylate Cohorts of 3-6 patients receive escalating doses of IFN-A and then imatinib mesylate until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive imatinib mesylate and IFN-A as in phase I at the established MTD
Patients are followed for 30 days
PROJECTED ACCRUAL Approximately 3-15 patients will be accrued for the phase I portion of this study Phase I closed to accrual as of 7903 A total of 40 patients will be accrued for the phase II portion of the study within 3-4 months
Determine the maximum tolerated dose of interferon alfa administered with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia Phase I closed to accrual as of 7903
Determine the safety and tolerability of this regimen in this patient population
Determine the complete major and minor cytogenetic response rates and complete hematologic response rate in patients after 6 and 12 months of treatment with this regimen
Determine the molecular response reverse transcriptase-polymerase chain reaction for bcr-abl rate in patients who have a complete cytogenetic response after 6 and 12 months of treatment with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Phase I closed to accrual as of 7903 Patients receive oral imatinib mesylate once daily beginning on day 1 and interferon alfa IFN-A subcutaneously once daily or 3 times weekly beginning on day 14 Courses repeat every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity After completion of 1 year of therapy patients may receive additional therapy provided that the patient is benefiting from imatinib mesylate IFN-A is discontinued in patients who achieve a molecular remission that is confirmed on 2 successive bone marrow samples Imatinib mesylate is discontinued in patients who achieve and maintain a molecular remission for 2 years
Sequential dose escalation of IFN-A is followed by sequential dose escalation of imatinib mesylate Cohorts of 3-6 patients receive escalating doses of IFN-A and then imatinib mesylate until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive imatinib mesylate and IFN-A as in phase I at the established MTD
Patients are followed for 30 days
PROJECTED ACCRUAL Approximately 3-15 patients will be accrued for the phase I portion of this study Phase I closed to accrual as of 7903 A total of 40 patients will be accrued for the phase II portion of the study within 3-4 months
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 |
|---|---|---|---|
| OHSU-HEM-00072-LX | Other Identifier | OHSU IRB | None |
| OHSU-6263 | OTHER | None | None |
| OHSU-409 | OTHER | None | None |
| NCI-2794 | None | None | None |