Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031915
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2002-03-08
Brief Title:
Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Gleevec Formerly Known as STI571 in Patients With Soft Tissue and Bone Sarcomas A Multi-Disciplinary Trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society
Status:
COMPLETED
Status Verified Date:
2003-10
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 tumor cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma
PURPOSE Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma
Detailed Description:
OBJECTIVES
Determine the efficacy of imatinib mesylate as measured by response rate in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens
Determine the clinical and laboratory toxic effects of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease subtype
Patients receive oral imatinib mesylate twice daily Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 60-120 patients 6-12 per stratum will be accrued for this study
Determine the efficacy of imatinib mesylate as measured by response rate in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens
Determine the clinical and laboratory toxic effects of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease subtype
Patients receive oral imatinib mesylate twice daily Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 60-120 patients 6-12 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-IRB-14060 | None | None | None |
| NCI-02-C-0097 | None | None | None |
| CCUM-2001-034 | None | None | None |