Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068783
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2003-09-10
Brief Title:
S0331 Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of STI-571Imatinib Gleevec NSC-716051 in Neuroendocrine Carcinoma of the Skin Merkel Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-02
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 metastatic or unresectable Merkel cell cancer Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the feasibility of a Southwest Oncology Group Phase II trial or oral STI-571imatinib Gleevec administered to patients with metastatic or unresectable Merkel cell carcinoma
II To evaluate the objective response probability confirmed and unconfirmed complete and partial responses of oral STI-571imatinib Gleevec administered to patients with metastatic or unresectable Merkel cell carcinoma
III To assess qualitative and quantitative toxicities of oral STI-581imatinib Gleevec administered to patients with metastatic or unresectable Merkel cell carcinoma
IV To analyze tumor samples for activating mutations of STI-571imatinib-sensitive kinases KIT PDGFRA PDGFRB by denaturing HPLC and direct DNA sequencing
OUTLINE This is a multicenter study
Patients receive oral imatinib mesylate once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression unacceptable toxicity or symptomatic deterioration
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
I To assess the feasibility of a Southwest Oncology Group Phase II trial or oral STI-571imatinib Gleevec administered to patients with metastatic or unresectable Merkel cell carcinoma
II To evaluate the objective response probability confirmed and unconfirmed complete and partial responses of oral STI-571imatinib Gleevec administered to patients with metastatic or unresectable Merkel cell carcinoma
III To assess qualitative and quantitative toxicities of oral STI-581imatinib Gleevec administered to patients with metastatic or unresectable Merkel cell carcinoma
IV To analyze tumor samples for activating mutations of STI-571imatinib-sensitive kinases KIT PDGFRA PDGFRB by denaturing HPLC and direct DNA sequencing
OUTLINE This is a multicenter study
Patients receive oral imatinib mesylate once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression unacceptable toxicity or symptomatic deterioration
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000328120 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0331 | None | None | None |
| U10CA032102 | NIH | None | None |