Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049192
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-11-12
Brief Title:
Oblimersen 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 II STUDY OF G3139 GENASENSE NSC 683428 IND 58842 IMATINIB MESYLATE GLEEVEC STI571 IN PATIENTS WITH IMATINIB-RESISTANT CHRONIC MYELOID LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in treating patients who have chronic myelogenous leukemia that has not responded to previous treatment with imatinib mesylate Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Oblimersen may help imatinib mesylate kill more cancer cells by making cancer cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the cytogenetic response rate of patients with CML who have had less than a complete hematologic response or less than major cytogenetic response to imatinib mesylate and who have been treated after two cycles of imatinib mesylate G3139
SECONDARY OBJECTIVES
I To estimate the hematologic cytogenetic and molecular response rate and duration in patients diagnosed with CML who have been treated after two and four cycles of imatinib mesylate G3139
II To estimate the toxicity of these two drugs given in combination in a cooperative group setting
OUTLINE
Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or twice daily Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients without a hematologic response after 2 courses go off study Patients with complete or partial response after 4 courses may continue to receive oral imatinib mesylate daily
Patients in cohort 2 receive an escalated dose of oblimersen if well tolerated subsequent cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate If oblimersen is not well tolerated in cohort 2 subsequent cohorts receive the original dose of oblimersen with an escalated dose of imatinib mesylate The first 6 patients accrued continue to receive the original dose dose taken prior to study of imatinib mesylate throughout the study
Patients are followed monthly for 3 months and then every 3 months for 5 years
I To estimate the cytogenetic response rate of patients with CML who have had less than a complete hematologic response or less than major cytogenetic response to imatinib mesylate and who have been treated after two cycles of imatinib mesylate G3139
SECONDARY OBJECTIVES
I To estimate the hematologic cytogenetic and molecular response rate and duration in patients diagnosed with CML who have been treated after two and four cycles of imatinib mesylate G3139
II To estimate the toxicity of these two drugs given in combination in a cooperative group setting
OUTLINE
Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or twice daily Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients without a hematologic response after 2 courses go off study Patients with complete or partial response after 4 courses may continue to receive oral imatinib mesylate daily
Patients in cohort 2 receive an escalated dose of oblimersen if well tolerated subsequent cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate If oblimersen is not well tolerated in cohort 2 subsequent cohorts receive the original dose of oblimersen with an escalated dose of imatinib mesylate The first 6 patients accrued continue to receive the original dose dose taken prior to study of imatinib mesylate throughout the study
Patients are followed monthly for 3 months and then every 3 months for 5 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 |
|---|---|---|---|
| CALGB 10107 | None | None | None |
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |