The Protocol Specific Research Core Facility will provide skilled and specialized research nursing support (3 FTEs) for the conduct of innovative Phase I and II clinical trials. These trials will be a) complex with strong correlative science and/or pharmacokinetic and pharmacodynamic components, b) UNC LCCC investigator-initiated, and c) primarily based on scientific expertise and interests ofUNC LCCC members. Trials will be selected from among those submitted to the PRC for review for novelty, complexity, and promise of therapeutic benefit. The Faculty Advisor, Dr. Beverly Mitchell, in direct consultation with Drs. Shea and Goldberg, co-leaders of the Clinical Research Program, will be responsible for the selection of trials and monthly monitoring for accrual and the use and quality of correlative studies. Progress over the last five years has been marked by the successful conduct of a number of innovative studies, including a pioneering Phase I study of PS341 (Bortezomib) in refractory multiple myeloma, a number of Phase I studies of Bortezomib in combination with other cytotoxic agents for solid tumors and refractory hematologic malignancies, and a novel dendritic cell vaccine study in metastatic breast cancer using a HER2 neu peptide custom-designed to enhance the immunologic response. Anticipated growth of the program is predicated on the number of similar studies under development or recently initiated. The increasing number of talented young clinical investigators, the growth of the Molecular Therapeutics Programs and the Clinical Research Program's Developmental Therapeutics focus, and the strong commitment of the UNC LCCC leadership to the development of novel therapeutics with molecular correlates or endpoints as a strategic direction create an environment that will generate even stronger demand for intensive research nursing support over the next five years. It is anticipated that we will have approximately nine such trials open at any given time and enroll an average of 100 patients annually.
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