The Clinical Core will provide the clinical trial infrastructure to support the clinical trial and related translational research that is generated by the four projects that constitute this SPORE application. The components of the Clinical Core leverage the extensive resources and expertise at MD Anderson in clinical and translational research. As the research efforts proposed in the current application represent extensions and expansions of ongoing efforts, the Clinical Core will continue to provide the support and expertise to develop and manage the highly innovative clinical trials that develop from the proposed research efforts. Additionally, recognizing that the scope of clinical trials may encompass from early stage (proof-of principle) studies examining drug/agent delivery and tissue-based efficacy (i.e. pharmacodynamics) to larger, randomized multicenter clinical trials, we have developed a robust web-based clinical trials management software package, the Data Management Initiative (DMI). This system supports state-of-the art tracking of all critical elements of the clinical trial including patient outcomes, adverse events and drug dosing. It contains internal auditing functions thereby limiting resource consuming queries. Furthermore, the DMI has been approved by the FDA for studies containing IND agents and is also approved for registration clinical trials. The Clinical Core will support the specific SPORE projects as described: Project 1: A Phase l/ll study combining the Delta-24 oncolytic virus with temozolomide. Early phase study of evaluating mesenchymal stem cell mediated delivery of Delta-24 into human glioblastoma. Project 2: A Phase I study of combination signal transduction agents followed by a 2-stage multi-arm Bayesian based Adaptive Selection Design clinical trial to test preclinical developed drug combinations. Project 3: No direct Clinical Core support needed for these clinical-molecular studies using outcomes and molecular profiles from large clinical trials. Project 4: A Phase I clinical trial of WPI 066 an oral STAT3 inhibitor with an arm that will evaluate treatment delivery and impact on molecular targets (pharmacokinetics and pharmacodynamics).
The Clinical Core will provide the clinical trials infrastructure to enable the innovative clinical studies that are developed within each of the SPORE projects to be completed with the highest level of oversight and data quality. The Clinical Core has developed resources to support early stage studies that examine treatment effects on the tumor to large scale multi-center studies.
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