PHASE 2: CCI-779 IN COMBINATION WITH BEVACIZUMAB IN STAGE III OR IV MELANOMA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multi site phase II evaluation of bevacizumab plus CCI-779, in participants with stage III or IV melanoma. Up to 23 participants will receive study treatment. The primary goal is to ascertain whether treatment with bevacizumab plus CCI-779 at the specified doses and schedule can produce sufficient clinical activity against melanoma to warrant further investigation. Treatment will consist of 26 cycles. Each cycle is 14 days. CCI-779 will be administered on days 1 and 8 of cycles 1-26. Bevacizumab will be administered on day 8 of cycles 1-26. Safety information will be monitored monthly on all participants throughout the study. A 2-staged design will be used to determine if accrual should be halted due to insufficient antitumor activity. This study is one of a series of National Cancer Institute sponsored studies participating in the Molecular Targeted Combinations Correlative (MTC2) Study Initiative to evaluate possible biomarkers that correlate with patient outcomes to treatment with targeted agents.