MENTORING FOR NEW CANCER THERAPEAUTICS

描述：(申请者描述)修订后的K24课程的目标 是允许首席调查员在翻译方面指导研究员 研究。在这次修订中，我们相信我们已经澄清了范围和 我们为研究员、住院医生和医务人员提供指导计划的环境 学生们以及我们的临床时间是如何被修改以满足这种不断扩大的需求 角色。此次修订还扩大了对临床研究的描述 程序。 PI目前的计划确定了新的药物，以增强诱导 化疗引起的细胞凋亡。这些临床观察直接导致了 临床试验。该计划是基于已发表的实验室研究结果，表明 蛋白激酶C(PKC)和细胞周期蛋白依赖性激酶(CDK)抑制剂 增强化疗对人胃、乳腺细胞的凋亡诱导作用 和结肠癌细胞系。这些研究已经导致了第一阶段 临床试验包括紫杉醇序贯试验、黄吡哆醇序贯试验和 其次是紫杉醇和Bryostatin-L。许多其他临床前观察 正在考虑转化为临床试验。事实上，基于 我们的实验室数据，UCN-01和5-FU的临床试验现在已经开放。在……里面 此外，五份意向书现已在NCI与新药一起到位 进行更多临床试验的组合。以支持这一努力 PI已获得国家癌症研究所拨款R01CA67819，题为 “蛋白激酶C：癌症治疗的新靶点。”除了这一点， 支持，该中心为他的实验室提供了补充支持， 临床工作。这里提出的职业生涯规划代表着直接的联系 在实验室和癌症治疗中的一种新治疗方法之间。这个 指导临床肿瘤学研究员和医务室工作人员是至关重要的 这是临床/转化性研究计划的一部分。我作为导师的角色 从研究员开始学习如何设计、实施和分析第一阶段和第二阶段 临床试验。临床试验方法学方面的教育由DIRECT 在一对一的基础上通过辅导和培训进行监督和教学 会议。首席调查员的研究员起草了协议， 通过回顾跟踪研究，在研究上治疗患者，管理数据， 监测反应和毒性，并废除结果。这些人负责监督 在我的直接监督下对临床试验中的病人进行治疗。AS 知情同意在临床研究中至关重要，研究员们 在书面同意书中得到了仔细的指导和监督。在 适当的时间，研究员组织、分析和解释数据以 在国家会议上的发言。一名接受过培训的临床研究员 翻译研究，谁能看到它从桌面到桌面的演变 临床，对医学肿瘤学的未来至关重要。这 K24奖励机制代表了我们所提议的和 需要哪种支持。

DESCRIPTION: (Applicant's Description) The goal of this revised K24 program is to allow the principal investigator to mentor fellows in translational research. In this revision we believe we have clarified the the extent and environment of our mentoring program for fellows, residents and medical students and how our clinical time is being modified to meet this expanding role. The revision has also expanded the description of the clinical research program. The PI's current program identifies new drugs that enhance the induction of apoptosis by chemotherapy. These clinical observations lead directly into clinical trials. The program is based on published laboratory studies showing that protein kinase C (PKC) and cyclin dependent kinase (CDK) inhibitors enhance the induction of apoptosis by chemotherapy in human gastric, breast, and colon cancer cell lines. These studies have already resulted in Phase I clinical trials including sequential paclitaxel followed by flavopiridol and paclitaxel followed by bryostatin-l. Numerous other preclinical observations are being considered for translation into clinical trials. In fact, based on our laboratory data, the clinical trials of UCN-01 and 5-Fu are now open. In addition, five letters of intent are now in place at the NCI with new drug combinations to perform additional clinical trials. To support this effort the PI has received a National Cancer Institute Grant R01CA67819, entitled "Protein Kinase C: A Novel Target for Cancer Therapy." In addition to this support, the Center has provided supplemental support to his laboratory and clinical work. The career plan presented here represents a direct connection between the laboratory and a new therapeutic approach in cancer therapy. The mentoring of clinical oncology fellows and medical house staff is a critical part of this clinical/translational research program. My role as mentor begins with fellows learning how to design, conduct and analyze phase I and II clinical trials. Education in clinical trial methodology is given by direct supervision and teaching on a one-to-one basis through tutoring and in conference. The fellows with the Principal Investigator write the protocol, follow the study through review, treat patients on the study, manage the data, monitor response and toxicity, and repeal results. The fellows oversee treatment of patients on the clinical trials under my direct supervision. As informed consent is of critical importance in clinical research, the fellows are carefully instructed and supervised in writing the consent form. At the appropriate time, the fellows organize, analyze and interpret data for presentation at national meetings. A clinical investigator trained in translational research, who can see its evolution from the benchtop to the clinic, is of paramount importance to the future of medical oncology. This K24 award mechanism represents the essence of what we are proposing and for which support is needed.