Single Source: Pediatric Early Phase Clinical Trials Network (PEP-CTN; UM1 Clinical Trial Required)

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Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to enhance NCIs program for conducting early phase clinical trials in children with cancer, thereby facilitating the introduction of high priority novel agents into the pediatric oncology setting in a timely manner. This ability to quickly conduct first in children studies is critical to NCIs overall clinical research program for children with cancer. The primary scope of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to design and conduct pediatric phase 1 trials that will often include phase 2 expansion cohorts. Conduct of the phase 2 study components within the PEP-CTN is efficient and allows intensive study monitoring for toxicity for these agents undergoing their initial evaluation in children. When phase 1 testing results for an agent are available, phase 2 studies will also be within the remit of the PEP-CTN. As well, the PEP-CTN will conduct pilot studies of novel regimens to determine their tolerability so that they can proceed to definitive testing in phase 3 clinical trials.

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