Protocol
10-102
Full Title
The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A Phase II, Open Label, Multi-center, Single-arm Study to Assess the Efficacy of Tasigna® in the Treatment of Patients with Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
Purpose
Dacarbazine is a chemotherapy drug commonly used to treat advanced melanoma. However, the cancer often continues to grow despite this treatment. In this study, researchers want to compare the drug nilotinib (Tasigna) with dacarbazine for the treatment of patients with metastatic or inoperable melanoma that harbors a mutation in the c-Kit gene.
Patients will receive one drug or the other. If patients initially receive dacarbazine and the cancer continues to grow, they will have the opportunity to then receive nilotinib.
Nilotinib is already approved for the treatment of chronic myelogenous leukemia (CML), but its use in patients with melanoma is considered investigational. It works by blocking the c-Kit protein. Imatinib — a drug like nilotinib that is also used to treat CML — has been shown to slow or stop the growth of c-Kit-mutated melanoma in some patients.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have inoperable or metastatic mucosal, acral, or cutaneous melanoma that contains a mutation in particular exons of the c-Kit gene (exons 11 or 13 or parts of 17).
- Patients may not have received prior treatment with dacarbazine or tyrosine kinase inhibitors.
- At least 4 weeks must have passed since completion of prior therapies and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Richard D. Carvajal at 646-888-4164.
Disease(s)
Melanoma
Locations
ClinicalTrials.gov
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