CLINICAL TRIALS AND MENTORING IN ONCOLOGY RESEARCH

K24的目标是允许首席研究员(PI)从事医学肿瘤学的临床研究，并指导新的研究人员。PI目前的计划为生殖器和泌尿系统恶性肿瘤患者确定了新的治疗方案，特别是睾丸癌和肾癌(RCC)。睾丸生殖细胞肿瘤(GCT)被认为是可治愈癌症的模型，70%的晚期GCT患者通过顺铂联合化疗治愈。然而，30%的耐药GCT患者需要更有效的治疗。研究工作集中在将剂量强化治疗纳入对预测为耐药的患者的一线治疗，新的剂量强化方法，以及识别具有抗肿瘤效果的新药物，并将其纳入联合治疗。相反，肾细胞癌是对化疗最耐药的恶性肿瘤。生物制剂，即干扰素-α，表现出较低的活性。针对肾癌的努力是针对增强干扰素活性的治疗方案的研究和抗肿瘤活性的新药物的研究。在过去的10年里，PI进行了23项机构审查委员会批准的I期、II期和III期预期临床试验。对于这两种肿瘤，已经建立了一个临床数据库来确定预后因素和指导治疗。作为一名临床研究员，参与翻译研究是我研究工作的基础。在担任医学部临床试验副主任的职位上，临床试验办公室由50名研究助理组成，负责该部门所有临床试验的流程和数据管理。将这一职位的影响应用到GCT和RCC的积极临床试验计划中，为医学肿瘤学研究员在教授临床试验方法学方面创造了一个独特的机会，作为一种全面的学习体验。接触到我们中心的一批受训研究员使这一点成为可能。临床试验方法论的教育是通过在临床、辅导和会议中一对一的直接监督和教学来进行的。强调临床试验操作的技巧，如编写方案、获得知情同意、反应和毒性评估以及所需数据的分析。在第二年和第三年的培训中，PI指导了10名正在接受培训的肿瘤学研究员；其中6人活跃在学术肿瘤学和/或临床调查员职业生涯中。其中一人最近加入了MSKCC生殖泌尿科的工作人员。临床试验的指导不仅仅限于对初级教员的奖学金。

The goal of this K24 is to allow the principal investigator (PI) to pursue clinical research in medical oncology and mentor new investigators. The PI's current program identifies new treatment programs for patients with genito-urinary malignancies, specifically testicular cancer and renal cell carcinoma (RCC). Germ cell tumor (GCT) of the testis is considered a model for the curable cancer, with 70 percent of patients with advanced GCT cured by cisplatin-combination chemotherapy. However, the 30 percent of patients with resistant GCT require more effective therapy. Research efforts focus on inclusion of dose-intensive therapy in first-line treatment for patients predicted as resistant, novel means of dose-intensification, and the identification of new agents with antitumor effect which are incorporated into combination therapy. In contrast, RCC represents the most resistant malignancy to chemotherapy. Biological agents, i.e. interferon-alpha, show a low degree of activity. Efforts against RCC are directed at the study of treatment programs to augment the activity of interferon and the study of novel agents for antitumor activity. During the past 10 years, the PI has conducted 23 phase I,II and III prospective Instituitional Reveiw Board-approved clinical trials. For both tumors, a clinical database has been established to identify prognostic factors and direct therapy. Participation in translational research is fundamental for my research effort as a clinical investigator. In the PI's position as Associate Chairman, Clinical Trials, Department of Medicine, the PI oversees the Clinical Trials Office, which is comprised of 50 research assistants and is responsible for process and data management of all clinical trials in the Department. Bringing the impact of this position to bear in an active clinical trial program in GCT and RCC creates a unique opportunity as a comprehensive learning experience for medical oncology fellows in teaching clinical trial methodology. Access to a cadre of fellows-in-training at our center makes this possible. Education in clinical trial methodology is given by direct supervision and teaching in a one-to-one basis in the clinic, through tutoring, and in conference. Skills of clinical trial conduct such as writing protocols, obtaining informed consent, response and toxicity assessment, and analysis of data requires are emphasized. The PI has mentored 10 medical oncology fellows-in training during their second and third year of training; six are active in academic oncology and/or clinical investigator careers. One recently joined staff at MSKCC in the Genito-urinary Section. Mentoring of clinical trials is extended beyond fellowship to junior faculty members.