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A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.
OBJECTIVES: Primary * To determine the proportion of participants with metastatic mucosal or acral/lentiginous melanoma who are alive and without disease progression at two months after beginning treatment with sunitinib. * To determine the best overall response rate. Secondary * To determine the time to progression and overall survival. * 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. * To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University in St. Louis
St Louis, Missouri, United States
Vanderbilt University
Nashville, Tennessee, United States
Start Date
August 1, 2007
Primary Completion Date
August 1, 2014
Completion Date
August 1, 2014
Last Updated
December 8, 2016
52
ACTUAL participants
Sunitinib
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
Collaborators
NCT01120275
NCT00470470
Data Source & Attribution
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