This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. This study will evaluate the safety and preliminary efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide for 14 consecutive days and DTIC on day one of each 21 day cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
MD Anderson Cancer Center
Houston, Texas, United States
To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment
To evaluate the safety profile of combination lenalidomide plus DTIC, the preliminary efficacy of combination lenalidomide plus DTIC
To define the recommended phase II doses of lenalidomide and DTIC when administered as combination therapy.
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