Phase 0/I/II Cancer Prevention Clinical Trials Program (Consortia)

COVID-19 is an emerging, rapidly evolving situation.


PLEASE NOTE: This is a reminder that infections occurring in subjects on clinical trials are considered adverse events, please see this additional guidance for reporting COVID-19 related adverse event.

Phase 0-I-II Prevention Clinical Trials Program Being Replaced with Grant Program

The National Cancer Institute is accepting applications for the Cancer Prevention Clinical Trials Network (CP-CTNet), a grant-funded network that will replace the contract-funded Phase 0-I-II Prevention Clinical Trials Program (Consortia). CP-CTNet will perform early phase clinical trials to assess the safety, tolerability, and cancer preventive potential of agents and interventions of varying classes, many of which target molecules or processes known to be important during carcinogenesis. For more information, visit the CP-CTNet page.

The Division of Cancer Prevention conducts systematic early clinical development of promising preventive agents through its Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials. Cancer prevention drug discovery is identifying many new agents, including an increasing number of agents that intervene in specific molecular pathways thought to be critical to cancer development. Since cancer prevention studies focus on high-risk populations that do not necessarily harbor a detectable cancer, these studies require extensive biomarker analysis, investigation of the biologic effects of the cancer preventive agents on their intended molecular targets, and correlation with clinically relevant endpoints.

The goals of the Consortia are:

  • To efficiently design and conduct early phase clinical trials necessary to assess the potential of cancer preventive agents of various classes, many of which are directed at molecular targets which have been shown to be expressed in intraepithelial neoplasia (IEN).
  • To characterize the biological effects of new cancer preventive agents on their defined molecular targets as well as on multiple endpoints associated with carcinogenesis, such as proliferation, apoptosis, growth factor expression, oncogene expression, and others.  Correlation of these effects with clinically relevant endpoints is required.
  • To develop further scientific insights into the mechanisms of cancer prevention by the agents examined and to continue to develop novel potential markers as determinants of response.

First funded in 2003, the consortia program was renewed in 2012 with five major medical research centers chosen to lead new studies:

  • University of Arizona, Tuscon, AZ - David Alberts, MD & Sherry Chow, PhD
  • Northwestern University, Evanston, IL - Seema A. Khan, MD & Lifang Hou, MD, PhD
  • Mayo Clinic Foundation, Rochester, MN - Paul Limburg, MD, MPH
  • M. D. Anderson Cancer Center, Houston, TX - Powel Brown, MD, PhD
  • University of Wisconsin-Madison, Madison, WI - Howard Bailey, MD

In addition to these centers, the University of California-Irvine, in Irvine CA, led by Frank Meyskens, MD, continues to carry out studies initiated through September 2012.

For additional information: