CANCER PREVENTION RESEARCH TRIALS

Cancer prevention research strives to prevent and control the malignant transformation of cells by using both empirical evidence and a mechanistic approach. This chapter discusses the experimental and epidemiologic evidence that leads to cancer-inhibiting agents and their application to human prevention research trials. The potential for reducing cancer incidence and mortality by preventive intervention is a unique and promising clinical research area. It involves the use of noncytotoxic dietary and pharmacologic agents to enhance intrinsic physiologic mechanisms to protect against the development and progression of carcinogenesis. The National Cancer Institute (NCI) chemopreventive agent development program develops compounds for diverse potential interventions and includes preclinical in vitro and in vivo screening and human clinical trials. These require a multidisciplinary approach from preclinical to human evaluation. The search for chemopreventive agents focuses on their biologic effects in the areas of cell biology and genetics, carcinogenesis, and epidemiology. Compounds that exhibit high efficacy and low toxicity in these preclinical tests are considered for preliminary evaluation in human phase I and II clinical trials in usually limited numbers of high-risk. Markers in the pathway of causality will be targeted for treatment to inhibit carcinogenesis. © 1993, Academic Press Inc.