Phase I Trials of Anti-Cancer Agents

描述（由申请人提供）：I期研究在开发新的癌症治疗方法中起着关键作用。这些试验是“首次人体”研究的基础研究和临床研究之间的初始接口。在最初发展的关键时期，成功的治疗研究体现了临床和实验室之间的反复过程。在过去，I期临床试验严格侧重于确定新药的毒性和药代动力学，而当前的重点是在不影响安全有效给药分析的情况下，有效地获取更多信息。这项任务要求实时获取药代动力学、药效学和药物基因组学以及细致的临床评估。在这项申请中，俄亥俄州立大学综合癌症中心（OSUCCC）的临床和基础科学研究人员加入了一项合作方法，开展新的癌症治疗药物和方案的I期试验。研究人员将与美国国家癌症研究所密切合作，开展相关研究，在基础科学观察的背景下评估临床结果。目前的应用建立在大约30年的经验和科学实力的OSUCCC进行临床试验与相关的生物学测量。试验将针对我们的教师具有临床前经验和/或实验室正在研究的细胞和分子网络的药物和策略。OSUCCC的实验治疗项目在信号转导途径、血管生成、细胞周期控制、肿瘤细胞凋亡的选择性诱导、单克隆抗体、分子遗传学、组蛋白修饰、DMA甲基化和其他基本靶向治疗策略方面具有专业知识。俄亥俄州立大学是世界上致力于跨学科研究的最全面的生物医学研究校园之一。在医学和公共卫生、药学、生物科学、数学和物理科学、兽医学、工程、牙科和护理等学院中，与癌症实验治疗相关的各自科学家形成了一个关键群体。这是一个I期临床试验项目，旨在实现在人体中进行权宜之计（但彻底）剂量寻找试验的最终目标，旨在为恶性疾病患者提供安全有效的新疗法。

DESCRIPTION (provided by applicant): Phase I studies play a critical role in the development of new cancer therapies. These trials are the initial interface between basic and clinical research for "first in human" studies. Successful therapeutic research embodies an iterative process between the clinic and the laboratory during this critical period of initial development. Whereas in the past, phase I trials focused strictly upon defining the toxicity and pharmacokinetics of new agents, the current emphasis requires that more information is efficiently procured without compromising the analysis of safe and effective administration. This mandate requires real-time procurement of pharmacokinetics, pharmacodynamics, and pharmacogenomics as well as meticulous clinical assessment. In this application, both clinical and basic science investigators of The Ohio State University Comprehensive Cancer Center (OSUCCC) join in a collaborative approach to conduct phase I trials of new cancer therapeutic agents and regimens. Investigators will cooperate closely with the National Cancer Institute in developing correlative studies to evaluate clinical outcomes in the context of basic science observations. The present application builds upon approximately 30 years of experience and the scientific strength of the OSUCCC in conducting clinical trials with pertinent biologic measurements. Trials will target agents and strategies with which our faculty has prior preclinical experience and/or cellular and molecular networks under study in their laboratories. The Experimental Therapeutics Program at OSUCCC has expertise in signal transduction pathways, angiogenesis, cell cycle control, selective induction of tumor cell apoptosis, monoclonal antibodies, molecular genetics, histone protein modification, DMA methylation and other basic targeted therapeutic strategies. The Ohio State University represents one of the most comprehensive biomedical research campuses in the world dedicated to interdisciplinary research. Respective scientists associated with experimental therapy of cancer form a critical mass within the Colleges of Medicine and Public Health, Pharmacy, Biological Sciences, Mathematical and Physical Sciences, Veterinary Medicine, Engineering, Dentistry, and Nursing. This is a Phase I clinical trials program designed to achieve the ultimate goals of expedient (yet thorough) dose-finding trials in man with the intention of providing safe and effective new therapy to benefit patients with malignant diseases.