Metastatic Melanoma Clinical Trial
Official title:
A Phase II Trial of Sutent in Metastatic Melanoma Patients With KIT Aberrations.
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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Phase 1 |