MAJOR ONGOING INITIATIVES

Early Clinical Trials (Phase 1-2 Program)

CTEP implements and monitors a comprehensive cancer therapy clinical contract/grant program that sponsors clinical trials of novel anticancer agents that have demonstrated high activity in animals in the preclinical phase of the cancer therapy development program.

In order to complete its agent development plans and to respond to new scientific opportunities, CTEP must be able to place phase 1 and 2 trials quickly. The restructured CTEP Phase 1-2 Early Clinical Trials Program is the main mechanism for completing early clinical trials for NCI's extensive therapeutics development program. It also provides the foundation for identifying the clinical activity that leads to definitive phase 3 clinical trials. The 14 phase 1 institutions are funded via cooperative agreements and participate in first-in-human and organ dysfunction trials in addition to dose-finding studies of combination therapies. Regarding the disease-focused phase 2 trials, 7 contractors and their affiliates, comprising nearly 30 NCI-designated Cancer Centers are involved in the program and generally serve as the nexus for the various clinical trials consortia. The phase 2 program has been very successful in increasing patient accrual, which increased four-fold over the first 5 years of its restructuring. In the past 5 years of the phase 2 program, 140 protocols studying several dozen investigational agents, both alone and in therapeutic combinations, were activated, with about half that number completed or closed. Nearly 5,000 patients were enrolled at the consortia institutions. This resource is critical for CTEP's therapeutics development as it provides an efficient way to obtain phase 2 results.

Due to the unique challenges posed by brain tumor studies, a specific brain tumor consortium has been developed to perform phase 1 and 2 clinical trials in adults with glioblastoma multiforme, and other brain tumors. A similar effort exists in childhood central nervous system (CNS) malignancies.