PHASE I TRIALS OF ANTICANCER AGENTS

描述：(申请人描述)在本申请中的临床和 俄亥俄州立大学综合基础科学研究人员 癌症中心(OSUCCC)携手合作， 进行新的癌症治疗药物和方案的I期试验。 这些研究人员将与癌症治疗密切合作 国家癌症研究所相关研究评估计划 它将在基础科学的背景下评估临床结果 观察。目前的建议是建立在OSUCCC优势的基础上 在进行具有相关生物测量的临床试验时。审判 根据这项提议进行的将强调那些药物和方案 OSUCCC的哪些教员以前有临床前工作经验和/或 申请者认为对细胞和分子的影响 他们的实验室正在研究网络。脱脂肽和脱脂肽的选择 拟议的第一阶段试验中的灯盏花素B反映了这些考虑因素。 因此，这两种药物的相关研究涉及到药代动力学。 和药物分析，细胞凋亡和信号转导， 微管、体内外拓扑异构酶实验室 测量。其他I期试验将利用DNA修复、生物学 反应调节剂、免疫反应、药效学与癌症 适用于新特工或团的化学预防实验室 我们正在进行调查。药物动力学将在以下方面发挥核心作用 临床和生物学终点的解释。数据管理和 通过计算机化数据和预期增强协议合规性 在临床实践中证明有价值的方案管理系统 审判。可用于I期试验的患者数量与 临床和基础科学合作研究的经验和专长 这项提案的参与者提供了一种有效的手段来带来新的 癌症制剂更快地传给癌症患者。在此基础上进行的研究 这项提议不仅将把新的治疗方法从替补席推进到床边， 而且还将提供对癌症生物学的洞察。这些洞察力反过来 将导致更合理的抗癌治疗。

DESCRIPTION: (Applicant's Description) In this application clinical and basic science investigators of The Ohio State University Comprehensive Cancer Center (OSUCCC) join together in a collaborative approach to the conduct of phase I trials of new cancer therapeutic agents and regiments. These investigators will cooperate closely with the Cancer Therapy Evaluation Program of the National Cancer Institute in correlative studies which will evaluate clinical outcomes in the context of basic science observations. The present proposal builds upon the strengths of the OSUCCC in conducting clinical trials with pertinent biologic measurements. Trials conducted under this proposal will emphasize those agents and regimens with which faculty of the OSUCCC have had prior preclinical experience and/or which the applicants identify as impacting on the cellular and molecular network under study in their laboratories. The choice of depsipeptide and halichondrin B for proposed phase I trials reflect those considerations. Thus, correlative studies for those two drugs involve t h e p harmacokinetic and pharmacoanalytic, the apoptosis and signal transduction, the microtubule, and the topoisomerase laboratories in in vivo and in vitro measurements. Other phase I trials will utilize the DNA repair, biological response modifier, immune response, pharmacodynamic, and cancer chemoprevention laboratories as appropriate for the new agent or regiment u n d er investigation. Pharmacokinetics will play a central role in interpretation of clinical and biologic end points. Data management and protocol compliance is enhanced by; computerized data and prospective protocol management system of proven value in the conduct of clinical trials. Patient numbers available for phase I trials coupled with the clinical and basic science collaborative research experience and expertise of this proposal's participants provide an effective means for bringing new cancer agents more rapidly to the cancer patient. Studies done under this proposal not only will advance new therapies from the bench to the bedside, but also will provide insights into cancer biology. These insights in turn will lead to more rational anticancer treatment.