Experimental Therapeutics of Anti-Cancer Agents with Phase I Emphasis

描述(由申请者提供)：这个项目包括一个由基础科学家和临床研究人员组成的多学科团队，致力于为癌症患者寻找有效的新疗法。俄亥俄州立大学综合癌症中心是一个真正全面的生物医学研究园区，经验丰富的研究人员之间有着强有力的合作，其中包括来自各自医学院、药剂学、公共卫生、护理和工程学院的教师。我们实验治疗计划的研究人员数十年来一直致力于L/11期癌症的研究。我们的患者群体支持NCI赞助的早期临床试验的强劲收益。每项临床试验都有一组科学家参与，结合了近乎实时的药代动力学、药效学和药物基因组学相关研究。我们与其他致力于实验疗法的中心进行了广泛的合作。在确定了新型药物的安全性和临床特征后，我们的研究人员继续进行战略联合方案的后续开发。虽然我们的数据已被用于支持FDA批准新药，但我们探索假设驱动的治疗试验。我们不是简单地测试药物。分子靶向治疗的未来、患者肿瘤的基因组图谱以及相关预测生物标记物的识别将在CTEP设计的临床研究中进行探索。除了对新型治疗剂的积极追求外，我们的多学科团队一直致力于培养致力于实验治疗学的下一代翻译科学家。我们的初级教员和博士后实习生有机会领导第一阶段的临床试验。我们的主要研究人员包括内科肿瘤学家、血液学家、放射肿瘤学家、妇科肿瘤学家和外科肿瘤学家。重点是指导，允许初级调查人员在经验丰富的监督下主持研究。基础科学家被邀请加入每个团队，制定意向书，设计临床试验，并参与发展疗法的科学发现。早期临床试验代表了我们改善患者生活的研究使命的长期重点。 相关性：该研究项目将为癌症患者确定新的治疗方法。在实验室研究中似乎很有希望的新药物被引入到癌症患者中，这些患者的选择受到标准治疗的限制。在给癌症患者服用这些新药物时，医生会观察对患者病情的影响。患者抽血以测试这些新疗法的安全性和有效性。如果一个代理人是有希望的，将根据这个信息计划进一步的研究。

DESCRIPTION (provided by applicant): This project encompasses a multi-disciplinary team of basic scientists and clinical investigators dedicated to finding effective new therapies for patiens with cancer. The Ohio State University Comprehensive Cancer Center is a truly comprehensive biomedical research campus with strong collaboration between the experienced investigators including faculty from the respective Colleges of Medicine, Pharmacy, Public Health, Nursing, and Engineering. Investigators in our Experimental Therapeutics Program have been engaged in phase l/ll cancer studies for decades. Our patient population supports robust accrual to NCI-sponsored early clinical trials. Each clinical trial engages a team of scientists with incorporatio of near real-time pharmacokinetics, pharmacodynamics, and pharmacogenomics correlative studies. We have collaborated extensively with other centers dedicated to experimental therapeutics. After defining the safety profile and clinical characteristics of novel agents, our investigators pursue the subsequent development of strategic combination regimens. While our data has been utilized in supporting new drug approvals by the FDA, we explore hypothesis-driven therapeutic trials. We do not simply test drugs. The future of molecular-targeted therapy, genomic profiling of a patient's tumor and the identification of relevant predictive biomarkers wil be explored in clinical studies designed with CTEP. In addition to vigorous pursuit of novel therapeutic agents, our multi-disciplinary team has been heavily engaged in educating the next generation of translational scientists dedicated to experimental therapeutics. Our junior faculty and post-doctoral trainees are provided with the opportunity to lead phase I clinical trials. Our principal investigators include medical oncologists, hematologists, radiation oncologists, gynecologic oncologists, and surgical oncologists. The emphasis is on mentoring allowing the junior investigators to chair the studies under experienced supervision. Basic scientists are invited to join each team in developing the letter of intent, designing the clinical trial, and the engaging in the scientific discovery of developmental therapy. Early clinical trials represent a longstanding emphasis of our research mission to improve patients' lives. RELEVANCE: This research project will identify new treatments for cancer patients. New agents that appear to be promising in the laboratory studies are introduced to cancer patients whose options are limited with standard treatment. In giving these new agents to cancer patients, the physicians observe the effects on the condition of the patient. Patients have blood drawn to test the safety and the effectiveness of these new treatments. If an agent is promising, further studies will be planned based on this information.