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Sponsors and Collaborators: |
California Pacific Medical Center Research Institute Pfizer University of California, San Francisco |
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Information provided by: | California Pacific Medical Center Research Institute |
ClinicalTrials.gov Identifier: | NCT00631618 |
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.
Condition | Intervention | Phase |
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Metastatic Melanoma |
Drug: Sutent (sunitinib) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II Trial of Sutent in Metastatic Melanoma Patients With KIT Aberrations. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
California Pacific Medical Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Ron Frianeza 415-600-3027 frianer@cpmcri.org | |
Principal Investigator: David R Minor, MD |
Principal Investigator: | David R Minor, MD | California Pacific Medical Center |
Study ID Numbers: | GA6181DN |
Study First Received: | March 3, 2008 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00631618 |
Health Authority: | United States: Institutional Review Board |
Neuroectodermal Tumors Sunitinib Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |