E2607 A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
The purpose of this study is to evaluate the tumor response rate and progression free survival of treatment with dasatinib in patients with advanced or metastatic acral, mucosal, or solar melanoma. Patients can be either treatment-naive or previously treated. The presence of KIT expression, amplification and mutation, and PDGFR expression in tumor samples will be done to correlate these parameters with response to treatment.
1.Age 18 or older. 2.History or melanoma of one of the following subtypes, confirmed metastatic or unresectable: Acral (occurring on palms, soles, or subungual-under the nail); Mucosal (arising on a mucosal surface); Chronic sun-damaged (the presence of loss of skin-elasticity in skin adjacent to the melanoma). 3.Prior systemic therapy or radiotherapy is allowed. No prior treatment with targeted therapies (i.e. imatinib or sutinib). 4.Patients with ocular melanoma are excluded. 5.No other current malignancies other than basal cell carcinoma, squamous cell carcinoma in situ, cervical cancer in situ, breast cancer in situ. History of other malignancies may be eligible if continuously disease free for more than 5 years. 6.No significant cardiovascular disease or uncontrolled hypertension.
Patients will receive dasatinib 70mg by mouth twice daily. The medication will be taken once in the morning and once in the evening with or without food. The cycle length is 21 days. There are no breaks between cycles. Patients who are tolerating treatment may continue on therapy until disease progression. Pre-study scans will be done within 4 weeks of stating treatment, then will occur every 6 weeks after study entry.
12/20/2013 04:02 AM