New Round of Studies Begin in Phase 0/I/II Cancer Prevention Clinical Trials Program

Date Posted: 

Monday, March 23, 2015

The NCI Division of Cancer Prevention’s Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials, is beginning a new round of studies in the effort toward systematic early clinical development of promising preventive agents for people at increased risk of developing cancer.

Cancer prevention research focuses on high-risk people who do not necessarily harbor a detectable cancer. The studies require investigation of the biologic effects of the preventive agents on the molecular targets; extensive biomarker analysis; and correlation with clinically relevant endpoints.

Program Director and Chief of the DCP Lung and Upper Aerodigestive Cancer Research Group, Eva Szabo, MD, noted that these latest efforts include vaccines for a variety of cancer preventive indications; aspirin’s effectiveness against detectable precursor lung nodules; and alternative dosing of non-steroidal anti-inflammatories (NSAIDS).

"The new emphasis on vaccines is partially motivated by an ever increasing understanding of the role of the immune system in cancer development and recent successes in cancer treatment," Dr. Szabo said. "We’re now examining vaccine approaches, both prophylactic and therapeutic, in the setting of premalignancy."

Based out of five major medical research centers, with more than 90 participating sites worldwide, the program is focusing on preventive vaccines, anti-inflammatory drugs, and defining biological markers of cancer risk. There are 22 sites open, or in the process of opening, to accrual across a geographic and ethnic minority spectrum in order to have access to different populations with unique issues, Dr. Szabo noted. Leading the new studies are the University of Arizona in Tucson; Northwestern University in Evanston, IL; Mayo Clinic Foundation in Rochester, MN; MD Anderson Cancer Center in Houston, TX; and the University of Wisconsin in Madison.

Eventually the program will have a biospecimen resource based on completed Consortia studies, but that may still be a year or so away.