Contact:
Eva Szabo, M.D.
Division of Cancer Prevention, NCI
Telephone: 301-435-1595
email: szaboe@mail.nih.gov

Objective of Project:
The objective of this initiative is to encourage applications for clinical and translational studies to develop effective chemopreventive strategies in former smokers. The following types of studies are sought: 1) Clinical trials (phase I/II, phase II) evaluating the efficacy of chemopreventive agents in specified cohorts of former smokers and 2) Translational studies performed on biologic specimens derived from ongoing or previously completed chemoprevention studies targeting former smokers.

Description of Project:
Former smokers, who are at continued risk for the development of tobacco-related malignancies, are more likely to benefit from chemoprevention approaches to reduce cancer incidence than are current smokers. For this reason, phase I and II clinical trials aimed at demonstrating safety and preliminary efficacy of putative chemopreventive agents are critical to the development of such chemopreventive strategies to reduce the risk of tobacco-related cancers in this population. With a number of promising agents currently available or in varying phases of development, prioritization of these agents is necessary before engaging in lengthy and large phase III clinical trials. This RFA is designed to support clinical trials with histologic and molecular biomarker endpoints to evaluate the preliminary efficacy of such agents in targeted populations of former smokers. In addition, translational studies aimed at identifying molecular signatures that may be used to predict the effectiveness of chemopreventive agents in this population will also be supported. The goals of this program are to identify agents and potential biomarkers within the context of phase I/II or phase II clinical cancer prevention trials in former smokers that merit evaluation in subsequent definitive phase III cancer prevention trials.