Cancer

Title
The Study of the Investigational Medication Cabozantinib Compared with Temozolomide for the Treatment of Ocular Melanoma
Trial Number
205590071713
Number of Participants
69
Principal Investigator

Joseph Clark

M.D.
Hematology/Oncology
Professor
Eligibility

Patients must be 18 years or older and have the following:
- Histologically or cytologically confirmed uveal melanoma that is metastatic or unresectable. If histologic or cytologic, confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma. Pathologic confirmation of diagnosis will be performed at the participating site.
- Measureable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as =20 mm with conventional techniques or as =10 mm with spiral CT scan or MRI for the evaluation of measurable disease.
- Prior therapies allowed, except for those treatments directed toward, or with activity against, c-Met or VEGF/R, and the chemotherapy agents temozolomide and dacarbazine. Including investigational cytotoxic chemotherapy or biologic agents (e.g., cytokines or antibodies) within the last three weeks, or nitrosoureas/mitomycin C within six weeks before the first dose of study treatment. At least six weeks must have elapsed if the last regimen included an anti-CTLA4 antibody. Patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator.

Purpose

The purpose of this study is to test whether a new treatment with an experimental drug, known as cabozantinib, is more effective than chemotherapy for treating ocular melanoma. Cabozantinib may work by blocking a protein called MET, which is often found to be an important cause of the growth and spread of ocular melanoma.

Enrollment

(708) 327-3221

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