Study oversight
toxicity, Cancer
CANCER
The study protocol and amendments were approved by the Memorial Sloan Kettering Cancer Center Institutional Review Board (IRB# 12-169, NCT01766739). All patients provided written informed consent to participate in the study, and all response and toxicity outcomes were documented. Patients were enrolled in groups of three and individually assessed for safety and dose-limiting toxicity. Inclusion and exclusion criteria are listed in the protocol (