Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424515
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2007-01-18
Brief Title:
Imatinib in Patients With Mucosal or AcralLentiginous Melanoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Imatinib in Patients With Mucosal or AcralLentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin
Status:
COMPLETED
Status Verified Date:
2016-06
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:
BUS255
Brief Summary:
The purpose of this study is to evaluate how effective imatinib Gleevec is in treating acrallentiginous and mucosal melanoma which has spread to other parts of the body in patients whos disease carries a c-kit mutation Imatinib is a protein-kinase inhibitor It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread
Detailed Description:
OBJECTIVES
Primary
To determine the response rate of patients with metastatic mucosal acrallentiginous or chronically sun damaged melanomas to treatment with of imatinib
To determine the time to progression
Secondary
To correlate c-kit mutational status with response to therapy
To evaluate the use of FDG-PET scanning in determining early biologic response to therapy
Tolerability of imatinib
To assess amplification of c-kit status through quantitative PCR andor FISH and other related molecular pathway targets
To correlate c-kit amplification status with response to therapy
Primary
To determine the response rate of patients with metastatic mucosal acrallentiginous or chronically sun damaged melanomas to treatment with of imatinib
To determine the time to progression
Secondary
To correlate c-kit mutational status with response to therapy
To evaluate the use of FDG-PET scanning in determining early biologic response to therapy
Tolerability of imatinib
To assess amplification of c-kit status through quantitative PCR andor FISH and other related molecular pathway targets
To correlate c-kit amplification status with response to therapy
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