Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025246
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2001-10-11
Brief Title:
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Adjuvant STI571 Gleevec TM Therapy in Patients Following Completely Resected High-risk Primary GastroIntestinal Stromal Tumor GIST
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To ascertain whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with STI571 have prolonged survival compared to historical controls
SECONDARY OBJECTIVES
I To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant STI571 following complete resection of high-risk primary GIST
II To obtain from patients with GIST tumor tissue before therapy with STI571 and at the time of recurrence blood specimens before therapy with STI571 and serum specimens before therapy with STI571 after completing therapy with STI571 and at the time of recurrence for scientific correlative analyses
III To assess the toxicity of oral STI571 therapy when used in the adjuvant setting
OUTLINE
Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 10 years
I To ascertain whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with STI571 have prolonged survival compared to historical controls
SECONDARY OBJECTIVES
I To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant STI571 following complete resection of high-risk primary GIST
II To obtain from patients with GIST tumor tissue before therapy with STI571 and at the time of recurrence blood specimens before therapy with STI571 and serum specimens before therapy with STI571 after completing therapy with STI571 and at the time of recurrence for scientific correlative analyses
III To assess the toxicity of oral STI571 therapy when used in the adjuvant setting
OUTLINE
Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 10 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 |
|---|---|---|---|
| CDR0000068942 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA076001 |
| ACOSOG-Z9000 | None | None | None |
| U10CA076001 | NIH | None | None |