PROTOCOL SPECIFIC RESEARCH SUPPORT

Protocol Specific Research Support (PSRS) supports the conduct of innovative, high-priority phase I and phase l-ll investigator-initiated trials led by AECC investigators. In order to be eligible for PSRS, the study must be led by AECC investigator or resulted from previous clinical or preclinical studies performed at AECC (with AECOM faculty as co-investigator). A process has been established for designating PSRS, which includes a screen by the CPDMU for eligibility, evaluating the scientific merit of the study (as determined by the PRMC), and assigning priority relative to other AECC investigator-initiated trials. During the last funding period, trials supported by PSRS included protocols evaluating the clinical and immune effects of an HspE7 vaccine in patients with CINIII, the clinical and biologic effects of combining the farnesyltransferase inhibitor tipifarnib with standard chemotherapy in locally advanced breast cancer, and defining the recommended phase II dose, pharmacokinetics, and pharmacodynamics of the epothilone B analog ixabepilone. These studies have led to additional CTEP-sponsored and industry-sponsored phase II and phase III trials evaluating the effects of HsPE7 patients with CINIII, tipifarnib in locally advanced breast cancer, and ixabepilone in patients with advanced breast cancer.