North American Star Consortium

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This UM1 renewal application is designated the North American Star Consortium (NASC), which includes Moffitt Cancer Center (MCC) as the Lead Academic Organization (LAO) with Daniel Sullivan, MD as the contact PI. MCC is joined by four highly productive Academic Organizations (AO) including Princess Margaret Cancer Center (PMCC; Philippe Bedard, MD, multi-PI), Virginia Commonwealth University-Massey Cancer Center (VCU-Massey; Steven Grant, MD, multi-PI), University of Texas Southwestern Simmons Cancer Center (UTSW; Muhammad Beg, MD, multi-PI), and Northwestern Lurie Cancer Center (NWU; Jeffrey Sosman, MD, multi-PI). The NASC evolved from the Princess Margaret Phase 1 Consortium (PMP1C), where PMCC was the LAO and MCC and VCU-Massey AOs. The two new sites (UTSW and NWU) bring additional depth in basic/translational science and biomarker (BM) development, have active early phase clinical trial programs, prioritize the accrual of minority patients, have active mentorship programs for Early Career Clinical Investigators (ECIs), and expand the NASC expertise in investigational imaging. The PMP1C has existed from April 2014 to the present and during this time 14 ETCTN trials have been activated and 4 are pending activation. The average yearly accrual during this time was 52 patients/year (yearly goal was 50 patients/year), with 97 patients enrolled March 2018 – February 2019. The 5 NASC institutions have enrolled a total of 1703 patients on their “top 50 trials” (ETCTN + non-ETCTN) with appropriate minority patient accrual, exceptionally strong mentoring of ECIs, and significant correlative molecular analyses for integrated and exploratory BM. This productivity of the PMP1C and UTSW/NWU will now go forward with MCC as the LAO to address the following specific aims. 1. To plan, develop, and activate novel phase 1 and phase 2 ETCTN trials through participation in the Project Team Member Application mechanism or as investigator-initiated trials (IITs) that emerge from NASC investigators. The NASC goal is to activate a minimum of six trials/year. 2. To enroll patients on ETCTN trials from the NASC or other sites that require the acquisition of high-quality tumor tissue for biomarker and pharmacodynamic analyses, include pharmacokinetic (PK) endpoints, and closely follow Good Clinical Practice and Human Subject Protection guidelines. The NASC annual accrual goal on ETCTN trials is a minimum of 100 patients/year (30 at MCC, 20 each at PMCC and VCU-Massey, and 15 each at UTSW and NWU). 3. To focus on the career development of ECIs within the NASC by providing educational opportunities regarding clinical research and its regulation at the 5 institutions, by having the ECI serve as the PI of ETCTN studies and pairing them with senior investigator mentors, and by focusing on ECI exposure and education regarding biomarkers, correlative molecular analyses, PK studies and precision cancer medicine. 4. To ensure that ETCTN trials performed at NASC sites have appropriate accrual of minority patients, other underserved populations, adolescent and young adults, the elderly, and rural populations.