Children's Hospital of Pittsburgh of UPMC Phase 1-2 Infrastructure Support Grant

Children's Hospital of Pittsburgh (CHP) has a long tradition of participation in pediatric oncology research. CHP is one of 21 institutions in the Children's Oncology Group (COG) Phase 1 Consortium and 1 of 10 in the Pediatric Brain Tumor Consortium (PBTC).  We enrolled the largest number of patients to PBTC trials and are the third highest enroller to COG Phase I studies this year. The CHP Neuro-Oncology program has two, and soon to be three, innovative vaccine trials open for children with central nervous system tumors and serves as the coordinating center for a multi-institutional Phase II trial of pegylated interferon for patients with plexiform neurofibromas.

Increasing patient numbers and regulatory burden, and the need to coordinate multiple evaluations, including pharmacokinetic analyses, are placing significant stress on our limited infrastructure of one research nurse, one CRA and one regulatory administrator. Budgetary constraints resulting from inadequate financial support provided by COG, PBTC and the institution have precluded hiring additional personnel. Additional clinical trials building on the experience from our initial vaccine studies are planned, including collaborative studies with pharmaceutical companies investigating combination studies with immunomodulatory agents. However, progress has been impeded by lack of research personnel.

We propose to utilize the ALSF Program Infrastructure Award to hire a second Clinical Research Associate (CRA) and a Patient Information Coordinator (PIC). With these new individuals in place, we will increase the number of available Developmental Therapeutic clinical trials and total patient accrual, and assure the future integrity of the CHP Developmental Therapeutics Program.