The University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet) is a major program funded by the National Cancer Institute, Division of Cancer Prevention (https://prevention.cancer.gov/major-programs/cancer-prevention-clinical-trials-network) to perform early phase clinical trials to evaluate the clinical activity and biologic effects of putative preventive agents and to determine clinically relevant correlates in order to identify agents with good safety profiles and preliminary efficacy. Scientific and clinical evidence generated from these early phase cancer prevention clinical trials will contribute significantly to the clinical development of safe and effective agents for cancer prevention.
The University of Arizona Cancer Center received an $8.6 million grant from the National Cancer Institute for the UA Cancer Prevention Clinical Trials Network, one of only five such networks funded by the NCI.
The UA CP-CTNet is an extension of the UA Early Phase Chemoprevention Consortium which has been funded continuously by NCI since 2003 to conduct early-phase clinical trials of chemopreventive agents.
Since its inception in 2003, the NCI-funded UA Chemoprevention Consortium has conducted 17 early phase cancer prevention clinical trials encompassing evaluation of repurposed drugs, well-characterized nutraceuticals, alternative dosing schedules, regional/topical drug delivery, and novel vaccines. Target organs include lung and upper aerodigestive cancers, HPV-associated cancers, breast prostate, skin, cervical and esophageal cancers.
Advances in molecular understanding of the process of carcinogenesis have led to the study of an increasing number of agents to intercept the early phases of cancer development, including the recent interest in immunoprevention. The overall objective of the UA CP-CTNet is to perform early phase clinical trials to evaluate the clinical activity and biologic effects of putative preventive agents, and to determine clinically relevant correlates in order to identify agents with good safety profiles and preliminary efficacy for definitive Phase III trials.
The UA CP-CTNet consists of the University of Arizona (UA) as the Lead Academic Organization (LAO) and 12 Affiliated Organizations (AOs) that work together to perform early phase cancer prevention clinical trials. This network is led by Drs. Julie Bauman https://cancercenter.arizona.edu/person/julie-e-bauman-md-mph and Sherry Chow https://cancercenter.arizona.edu/person/hsiao-hui-sherry-chow-phd and is composed of a team of physicians from diverse specialties, statisticians, clinical staff, data managers, pathologists, translational scientists, and other personnel with extensive experience in early phase (phase 0, 1 or 2) clinical trials of cancer preventive agents and in translational research in various organ sites.
The 12 Affiliate Organizations are:
British Columbia Cancer Agency
George Mason University
Johns Hopkins University
Moffitt Cancer Center
Norton Thoracic Institute
Oregon Health & Science University
University of California San Diego
University of Minnesota
University of North Carolina
University of Southern California
Investigators in the UA CP-CTNet are organized into five organ system groups to facilitate scientific interactions among investigators at the LAO and AOs with shared interests. Core personnel provide oversight and coordination of development of study concepts, protocol development, participant accrual, study conduct, trial endpoint evaluation, and study manuscripts/abstracts preparation and submission. The collaboration in UA CP-CTNet cover a wide range of transdisciplinary expertise that offers the opportunities of developing agents for melanoma and non-melanoma skin cancer prevention, lung and upper aerodigestive cancer prevention, breast and gynecologic cancer prevention, prostate and urologic cancer prevention, and gastrointestinal cancer prevention.
The overall objective of University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet) is to perform early phase clinical trials to evaluate the clinical activity and biologic effects of putative preventive agents and to determine clinically relevant correlates to identify agents with a good safety profile and preliminary efficacy for definitive trials.
Aim One: Efficiently design and conduct Phase 0/I/II clinical trials to assess the cancer preventive potential of repurposed drugs that affect multiple chronic diseases, well-characterized nutraceutical agents, regional/topical drug delivery, and immune modulators, rigorously identified from translational research, epidemiological studies, and/or clinical research.
Aim Two: Characterize the clinical activity and biological effects of putative cancer preventive agents on their defined molecular/biochemical targets, the immune surveillance network, surrogate endpoints associated with carcinogenesis, and other biological effect markers identified in preclinical studies.
Aim Three: Develop further scientific insights into the mechanisms of cancer prevention by the agents studied and to develop novel potential markers as determinants of response and for selecting subpopulations who may differentially benefit from the studied agent.
Through the conduct of rigorously designed early phase cancer prevention clinical trials, the UA CP-CTNet will determine the clinical activity and biological effects of potential preventive agents. The research findings will further scientific insights into the mechanisms of cancer prevention and develop novel potential biomarkers as determinants of response. Scientific and clinical evidence generated from these early phase cancer prevention clinical trials will contribute significantly to the decision for advancing a candidate agent for further clinical development for cancer prevention.
The collaboration in UA CP-CTNet cover a wide range of transdisciplinary expertise that offer the opportunities of developing agents for:
- Melanoma and Non-Melanoma Skin Cancer Prevention
- Lung and Upper Aerodigestive Cancer Prevention,
- Breast and Gynecologic Cancer Prevention,
- Prostate and Urologic Cancer Prevention
- Gastrointestinal Cancer Prevention.
Currently, there are two NCI-supported UA CP-CTNet trials pending activation:
- An Extended Follow-up Study of the HPV Vaccine Delayed Booster Trial
- Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy
For More information on the UA CP-CTNET please contact the University of Arizona Cancer Prevention Clinical Trials Network at 520-321-7444 OR UACC-CPRE@UACC.arizona.edu