UAB 0540 - PHASE I STUDY OF CS-1008 FOR PATIENTS WITH ADVANCED TUMOR OR LYMPHOMA

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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. The primary objective of this study is to determine a recommended Phase II dose (RP2D) and document the safety profile for CS-1008, administered by weekly intravenous infusion to patients with advanced solid tumor or non-leukemic lymphomas. The protocol will be conducted as an open-label Phase I, dose-escalation study of CS-1008 in sequential cohorts of 3 to 6 patients with advanced solid tumor or lymphoma malignancies. A treatment cycle is arbitrarily defined as 3 weeks of once weekly treatment. Investigational drug will be administered weekly over two sequential 3-week cycles (i.e., 6 weeks), and will be continued without interruptions for up to 12 cycles in patients with complete response (CR) or partial response (PR), and for up to 4 cycles in patients with stable diseas(SD), in the absence of dose-limiting toxicity (DLT), as defined per protocol, or progressive disease (PD). Patients will be accrued in cohorts of three to six, beginning at dose level 1. Initiation of the next dose-level cohort will occur only after at least three patients in prior dose cohort have completed one cycle of treatment (3 weeks). Sixteen to 40 patients with advanced solid tumor or lymphoma malignancies are expected to be enrolled, depending on the number of dose escalations required to determine the recommended Phase II dose.