The goal of this application is to develop and perform early clinical trials with new anti-cancer agents sponsored by the NCI Cancer Therapy Evaluation Program. Discovery and clinical evaluation of new anti- cancer agents is one of the highest strategic objectives of the Cancer Institute of New Jersey (CINJ), the only NCI-designated comprehensive cancer center in New Jersey. From its inception, CINJ has focused on development of early clinical trials with a translational emphasis. CINJ clinical investigators have an outstanding record of translational clinical trial development, including pharmacokinetic/biomarker studies in several phase I/pilot trials supported by grants from the NCI. This expertise encompasses a wide range of drug targets, including cellular signaling pathways as well as novel immunologic, DNA-, and microtubule- associated targets. From 2004-2006, 42 phase I or pilot trials were active at CINJ, with an average annual accrual of 151 patients to these trials. Scientific themes within these studies included statistically driven dose- and schedule-finding algorithms, as well as validation of target modulation by biochemical studies of cancer tissues. CINJ provides an exceptional and unique resource for early clinical trials of new anti-cancer agents. Expected to reach a population of 9,000,000 by 2008, New Jersey has the highest population density in the United States, with an average of 1,174 people per square mile, which is 13 times the national average. Approximately 70,000 patient visits occur yearly at the main CINJ facility, and over 6000 new patients are seen each year. A statewide network of affiliated institutions facilitates referral for early clinical trials. CINJ has an outstanding clinical research infrastructure provided by several Shared Resources, including Biometrics, Centralized Education and Training Services for Clinical Research Personnel, Office of Human Research Services, Pharmacokinetics/Pharmacodynamics, Research Pharmacy, and Tissue Retrieval Services. Clinical informatics resources include electronic order entry, electronic clinical documentation, and a web-based clinical trials database that allows online monitoring of trial development, accrual, adverse events, and responses, as well as electronic data sharing with NCI trial monitoring systems.
