MENTORING FOR NEW CANCER THERAPEAUTICS

描述：（申请人的描述）这个修订的K24计划的目标 是允许首席研究员指导研究员进行翻译， research. 在这次修订中，我们认为我们已经澄清了 我们为研究员，居民和医疗指导计划的环境 学生和我们的临床时间是如何被修改，以满足这一扩大 作用 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，提高诱导 化疗引起的细胞凋亡。 这些临床观察结果直接导致 临床试验 该计划基于已发表的实验室研究， 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， 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给药， 紫杉醇，然后是苔藓抑素-L。 许多其他临床前观察结果 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的临床试验现已开放。 在 此外，NCI现在有五份意向书， 联合用药进行额外的临床试验。 支持这一努力 PI已经收到了国家癌症研究所的R01CA67819拨款， 蛋白激酶C：癌症治疗的新靶点。"除此之外 支持，该中心提供了补充支持，他的实验室， 临床工作。 这里提出的职业规划代表了一种直接的联系 实验室和癌症治疗的新方法之间的关系。 的 临床肿瘤学研究员和医务室工作人员的指导是一个至关重要的 临床/转化研究项目的一部分。 我作为导师的角色 首先是研究员学习如何设计、实施和分析第一阶段和第二阶段 临床试验 临床试验方法学教育由直接 一对一的指导和教学，通过辅导和 会议 研究员和主要研究者一起编写方案， 通过审查跟踪研究，治疗研究患者，管理数据， 监测反应和毒性，并撤销结果。 研究员们监督 在我的直接监督下治疗临床试验中的病人。 作为 知情同意在临床研究中至关重要， 在知情同意书的撰写过程中得到认真指导和监督。 在 在适当的时候，研究员组织，分析和解释数据， 在国家会议上发言。 接受过以下培训的临床研究者 翻译研究，谁可以看到它的演变，从台式到 临床，对肿瘤医学的未来至关重要。 这 K24奖励机制代表了我们所建议的本质， 需要哪些支持。

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.