A program of immune-based treatments for cancer

描述（由申请人提供）：本提案的目标是将Carson博士实验室的免疫学发现转化为癌症患者的临床试验，并将该研究项目作为培训年轻医生进行以患者为导向研究的手段。一些最令人兴奋的抗癌新疗法是基于免疫学的发现。重组细胞因子和单克隆抗体现在通常用于治疗癌症患者。卡森博士的临床项目主要集中在两个特定的研究领域：1)。2)使用免疫刺激化合物增强对治疗性抗肿瘤单克隆抗体的免疫反应。使用细胞因子单独或联合靶向药物治疗转移性黑色素瘤患者。这里介绍的大多数试验都是从卡森博士免疫学实验室的基本实验观察发展而来的。Carson博士的试验是独一无二的，因为他们结合了一系列深入的相关研究，旨在评估治疗方案对患者免疫系统活动和患者肿瘤生长的影响。这些实验室研究允许对免疫治疗方案进行合理评估，并指导后续试验的发展。此外，他们还允许Carson博士从NCI和其他外部来源为他的临床研究吸引资金。结合这些临床活动，Carson博士为年轻研究者开发了以患者为导向的研究系统培训计划。俄亥俄州立大学综合癌症中心的许多内科和外科肿瘤研究员、外科住院医师和早期职业助理教授参与了Carson博士临床试验的开发和实施。该项目的目标是通过与患者的直接互动和专门的辅导课程，教会参与者如何生成和管理他们自己设计的协议。受训者还将参加一系列的肿瘤学教学课程，并定期与卡森医生会面，讨论他们的病人和他们的教育经历。Carson博士在一项有或没有抗血管生成药物（贝伐单抗，阿瓦斯汀）的化疗随机试验中担任国家P.I.的角色，确保学员也将获得这方面临床研究的宝贵经验。最后，特别强调的是与以病人为导向的研究的伦理行为有关的指导。

DESCRIPTION (provided by applicant): The goals of this proposal are to translate immunologic discoveries from Dr. Carson's laboratory into clinical trials for cancer patients and to use this research program as a means of training young physicians in patient-oriented research. Some of the most exciting new anti-cancer therapies are based on immunologic discoveries. Recombinant cytokines and monoclonal antibodies are now routinely used to treat cancer patients. Dr. Carson's clinical program has focused on two specific areas of investigation: 1). The use of immunostimulatory compounds to augment the immune response to therapeutic anti-tumor monoclonal antibodies, and 2). The use of cytokines alone or in combination with targeted agents to treat patients with metastatic melanoma. The majority of the trials presented here have evolved from basic experimental observations that were made in Dr. Carson's immunology laboratory. Dr. Carson's trials are unique in that they incorporate a series of in-depth correlative studies designed to evaluate the effects of the treatment regimen on the activity of the patient's immune system and the growth of the patient's tumor. These laboratory studies have permitted a rational evaluation of the immunotherapeutic regimens and have guided the development of subsequent trials. In addition, they have allowed Dr. Carson to attract funding for his clinical research from the NCI and other extramural sources. In conjunction with these clinical activities, Dr. Carson has developed a systematic training program in patient-oriented research for young investigators. A number of Medical and Surgical Oncology Fellows, surgical residents, and early career Assistant Professors at the Ohio State University Comprehensive Cancer Center have participated in the development and conduct of Dr. Carson's clinical trials. The goal of this program is to teach participants how to generate and administer protocols of their own design via direct patient interaction and specialized tutorial sessions. Trainees will also attend a series of oncologic didactic sessions and meet regularly with Dr. Carson to discuss their patients and their educational experiences. Dr. Carson's role as national P.I. on a randomized trial of chemotherapy with or without an anti-angiogenic drug (bevacizumab, Avastin(tm)) insures that trainees will also gain valuable experience in this aspect of clinical research. Finally, a special emphasis has been placed on instruction relating to the ethical conduct of patient-oriented research.