The Atlantic Coast Phase 2 Consortium (ACP2C) with Johns Hopkins serving as the lead academic organization (LAO) will expand upon the existing Johns Hopkins UM1-funded phase I trials infrastructure to conduct highly translational phase 2 trials of promising new therapies for patients with malignant disease in a clinically efficient, regulatory compliant, and scientifically rigorous collaborative research environment. Building upon a strong foundation in the conduct of early phase trials, we have assembled an interactive and interdisciplinary phase 2 team from six geographically and scientifically aligned NCI-designated cancer centers: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (JHKCC)(LAO), Emory Winship Cancer Institute (EWCI), Georgetown Lombardi Comprehensive Cancer Center (LCCC), Memorial Sloan Kettering Cancer Center (MSKCC), Sidney Kimmel Cancer Center at Thomas Jefferson University (TJU), and University of Virginia Cancer Center (UVACC). The ACP2C has five aims:
Aim1 - To contribute collaboratively and actively in the NCI Experimental Therapeutics-Clinical Trials Network (ETCTN) with Phase II Emphasis as a team member through an expanded Hopkins-led Consortium.;
Aim 2 - To conduct informative Phase ll clinical trials of novel anti-cancer agents in a timely manner.;
Aim 3 -To incorporate and implement innovative correlative and biological laboratory studies in the context of or as eligibility for participation in Phase II studies to enhance our understanding of determinants of toxicity and response that will be used for further definitive practice-changing clinical trial evaluation.;
Aim 4 - To maintain a coordinated clinical trial infrastructure that is current and compliant with regulatory standards to assure quality care to patients enrolled on early phase clinical trials as well as provide prompt data sharing with other investigators and interested parties.;
and Aim 5 - To train the next generation of investigators in drug development. Through these aims and with a focus on team science and collaboration across ACP2C led phase 2 trials, the Johns Hopkins leadership of this UM1 supplement is committed to the success of the NCI ETCTN. We anticipate that we will easily meet the required 100 phase 2 patients/year accrual. We will support the ETCTN CIRB and adhere to other metrics of the Operational Efficiency Working Group to assure timely activation, completion, and dissemination of our findings.
Our Team will expand upon its long-standing contribution to the drug development efforts of the NCI Experimental-Therapeutics Clinical Trials Network (ETCTN) through the creation of the Atlantic Coast Phase 2 Consortium (ACP2C), a collaboration of scientifically aligned NCI-designated cancer centers which have coalesced with the uniform goal of conducting highly translational phase 2 clinical trials of NCI ETCTN novel therapeutics. We anticipate that the ACP2C contributions within the Network will impact the clinical care of cancer patients. We anticipate enhanced interactions with the National Clinical Trials Network (NCTN) through our ECOG-ACRIN/Alliance primary affiliations to bring forward successes from the efforts of the ET-CTN.
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