Clinical Trial of Sutent to Treat Metastatic Melanoma
The purpose of this study is to investigate whether an investigational drug called sunitinib malate is safe and effective in treating metastatic melanoma in patients with KIT mutations.
KIT is a gene that "codes for" (contains the genetic code that the body uses to make) a protein on the surface of cells in your body that is important in cell growth and cell division. The KIT protein seems to play a role in abnormal cell growth seen in acute leukemia, germ cell tumors, gastrointestinal stromal tumors (GIST), and certain melanomas. Melanomas that arise on acral skin (palms, soles, nail beds), mucosal membranes, and chronically sun damaged skin have recently been found to frequently contain mutations or increased copy numbers of the KIT gene. Your tumor tissue has previously been tested and has been found to contain abnormalities in the KIT gene.
Sunitinib malate is drug that has been shown to inhibit the activity of the KIT protein. The FDA approved sunitinib in 2006 for patients with GIST. It has been shown that sunitinib malate works in these patients because of its activity against the KIT protein. The FDA also approved Sunitinib malate in 2006 for the treatment of metastatic kidney cancer, where its effectiveness is probably due to its ability to block a different set of proteins.
Sunitinib malate has not been approved by the FDA for the treatment of metastatic melanoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Sutent in Metastatic Melanoma Patients With KIT Aberrations.|
- Determine the objective response rate of metastatic melanoma patients with KIT aberrations to therapy with sunitinib. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Study the safety and toxicity of sunitinib when given to metastatic melanoma patients with KIT aberrations. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Drug: Sutent (sunitinib)
The initial dose will be 50mg daily taken for 4 consecutive weeks followed by 2-weeks off to comprise a complete cycle of 6 weeks.
Other Name: sunitinib malate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631618
|United States, California|
|California Pacific Medical Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||David R Minor, MD||California Pacific Medical Center|