Protocol - Specific Research Support

PROJECT SUIVIMARY (See instructions): Protocol Specific Research Support (PSRS) supports innovative investigator-initiated pilot, phase 0, phase I, and phase l-ll trials led by AECC investigators. AECC leadership oversees these funds and provides support for research nurse or data managers for studies judged to be of high scientific priority by the PRMC. Eligibility for PSRS support requires that: (i) the study must be led by an AECC investigator, (ii) the study involves testing a candidate agent or device for diagnosis, prevention or treatment of cancer, (iii) the study can be completed within a reasonable period of time (usually < 2 years) and (iv) the study not be fully funded by another mechanism. A process has been established for designating PSRS support for these pilot trials, which includes a screen by the CPDMU and PSRS Directors for PSRS eligibility, evaluation of scientific merit (as determined by the PRMC), and assigning priority relative to other AECC investigator initiated trials with a final recommendation by the Clinical Research Executive Committee. During the last funding period, trials supported by PSRS included a phase I first in human study of oncolytic virus Reolysin in patients with solid tumors, a phase I study of a combination of anti-CD19 and anti-CD22 immunotoxin (Combotox) in patients with hematological malignancies, and studies evaluating the clinical and biological effects of histone deacetylase and farnesyl transferase inhibitors in breast cancer. Other ongoing phase 0 or phase l-ll studies supported by PSRS include Combotox in combination with chemotherapy in leukemia, metronomic dosing of the PARP inhibitor veliparib and oral cyclophosphamide in breast cancer, and trials evaluating AKT inhibitors in breast cancer.