This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib. II. Determine the progression-free survival of patients treated with this drug. SECONDARY OBJECTIVES: I. To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections. II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1. III. To assess toxicity. OUTLINE: Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Yale University
New Haven, Connecticut, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria
Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.
Time frame: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
Progression-free Survival
Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used
Time frame: Time from start treatment to time of progression, assessed up to 6 months
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