Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091078
Status:
TERMINATED
Last Update Posted:
2013-06-05
First Post:
2004-09-07
Brief Title:
Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIA Study to Determine the Safety and Efficacy of A NCI-Supplied Agent G3139 NSC 683428 IND 58842 and Imatinib Mesylate in Patients With Refractory or Relapsed Gastrointestinal Stromal Tumor
Status:
TERMINATED
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:
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth Oblimersen may help imatinib mesylate kill more tumor cells by making tumor cells more sensitive to the drug This phase II trial is studying how well giving imatinib mesylate together with oblimersen works in treating patients with advanced gastrointestinal stromal tumor that cannot be removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of G3139 bcl-2 antisense oligonucleotide plus imatinib mesylate in GIST patients with limited or generalized progression after therapy with imatinib
II To assess the safety of G3139 plus imatinib mesylate in GIST patients with limited or generalized progression after therapy with imatinib
III To determine whether expression of BCL-2 correlates with survival time to progression or response rate in patients with GIST treated with G3139 plus imatinib
OUTLINE This is a multicenter study Patients are stratified according to extent of disease progression limited vs generalized
Patients receive oblimersen IV continuously on days 1-14 Patients also receive oral imatinib mesylate on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 96 patients 48 per stratum will be accrued for this study
I To determine the efficacy of G3139 bcl-2 antisense oligonucleotide plus imatinib mesylate in GIST patients with limited or generalized progression after therapy with imatinib
II To assess the safety of G3139 plus imatinib mesylate in GIST patients with limited or generalized progression after therapy with imatinib
III To determine whether expression of BCL-2 correlates with survival time to progression or response rate in patients with GIST treated with G3139 plus imatinib
OUTLINE This is a multicenter study Patients are stratified according to extent of disease progression limited vs generalized
Patients receive oblimersen IV continuously on days 1-14 Patients also receive oral imatinib mesylate on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 96 patients 48 per stratum will be accrued for this study
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 |
|---|---|---|---|
| 2003-0761 | None | None | None |
| 6122 | None | None | None |
| N01CM62202 | NIH | None | httpsreporternihgovquickSearchN01CM62202 |