Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection
In this Phase II trial, chemotherapy-naïve patients with palpable Stage III or Stage IV M1a
melanoma scheduled to undergo surgical resection will be treated with TMZ in 8 week cycles
according to the extended dosing schedule of 75mg/m2/day x 6 weeks with 2 weeks off.
Patients will be treated until maximal response to TMZ and then undergo resection of
residual disease. The primary endpoint will be tumor response as measured by the RECIST
criteria. Patients will be seen monthly.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall objective response rate (CR and PR)
Paul Chapman, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|