University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet)

项目摘要 对致癌过程的分子理解的进展导致了对越来越多的癌症的研究。 许多药物拦截癌症发展的早期阶段，包括最近的兴趣， 免疫预防亚利桑那大学癌症预防临床试验网络（UA）的总体目标 CP-CTNet）是进行早期临床试验，以评估假定的预防药物的生物效应 并确定临床相关性，以确定具有良好安全性特征的药物， 确定性III期试验的疗效。 UA CP-CTNet由来自不同专业的医生，统计学家，临床工作人员，数据 管理人员、病理学家、转化科学家和其他在早期阶段具有丰富经验的人员 癌症预防剂的临床试验和各种器官部位的转化研究。 具体而言，UA CP-CTNet将： ·有效地设计和进行0/I/II期临床试验，以评估癌症预防潜力 影响多种慢性疾病的重新利用的药物，充分表征的营养药物， 区域/局部药物递送和免疫调节剂，从转化研究中鉴定， 流行病学研究和/或临床研究。 ·表征推定的癌症预防剂对其肿瘤的临床活性和生物学效应。 确定的分子/生化靶点、免疫监视网络、相关替代终点 与致癌作用和临床前研究中鉴定的其他生物学效应标志物有关。 ·通过所研究的药物进一步科学地了解癌症预防的机制， 开发新的潜在标志物作为反应的决定因素，并选择亚群， 可能会从所研究的药物中获益。 通过拟议的研究，我们希望进行严格设计的早期癌症预防临床 确定潜在预防剂的临床活性和生物学效应的试验。研究 这些发现将进一步科学地了解癌症预防的机制，并开发新的潜力。 生物标志物作为反应的决定因素。从这些早期阶段产生的科学和临床证据 癌症预防临床试验将对进一步临床开发的“去-不去”决策做出重大贡献 预防癌症的潜在药物

PROJECT SUMMARY 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 University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet) is to perform early phase clinical trials to evaluate the 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 a team of physicians from diverse specialties, statisticians, clinical staff, data managers, pathologists, translational scientists, and other personnel with extensive experience in early phase clinical trials of cancer preventive agents and in translational research in various organ sites. Specifically, the UA CP-CTNet will: • 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, identified from translational research, epidemiological studies, and/or clinical research. • 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. • 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 proposed research, we expect to conduct rigorously designed early phase cancer prevention clinical trials that 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 “go-no go” decisions for further clinical development of putative agents for cancer prevention.