PHASE I CLINICAL TRIAL OF ANTICANCER AGENTS

将新的抗肿瘤药物引入临床试验仍然是 临床肿瘤学研究中最重要的领域之一。 到 确保患者的护理和治疗不断取得进展， 癌症似乎可以肯定的是，研究人员将需要建立在 现有的治疗方法部分通过引入新的药物 和新的模式。 这些特工要想取得进展 顺利通过早期临床试验， 在能够进行及时和可靠研究的机构进行评估 执行。 这些研究的重要内容， 在I期或早期II期研究中进行的研究包括： 1. 收集完整准确的临床信息， 患者治疗。 这应包括监测日常活动， 临床和实验室参数以及终末器官的变化 临床前毒理学或早期临床经验提示的功能 (e.g.,心脏、肺、神经系统）; 2. 进行详细的药理学和药代动力学研究 并试图将这些观察结果与 重要临床终点; 3. 在可能的情况下，开展旨在评估 药物在目标靶组织中的药效学后遗症;以及 4. 进行辅助实验室研究， 临床观察中提出的重要问题 审判 尽管执行这些任务中的每一项都可能需要 因此，重要的是要把它们放在一起考虑。 存在 一组调查员，有能力进行这种调查， 研究，并在此类项目上有成功合作的历史 将确定一个新的药物开发机构， 以高效和有效的方式进行。 本提案将试图证明命名的能力 调查人员利用法庭现有的设施和资源， 约翰霍普金斯肿瘤中心和医学院进行临床 和高质量的药理学研究。

The introduction of new antineoplastic agents into clinical trial remains one of the most important areas of investigation in clinical oncology. To assure continued progress in the care and treatment of patients with cancer it seems certain that investigators will need to build on the existing therapeutic approaches in part by the introduction of new agents and new modalities into these programs. For these agents to progress smoothly through early clinical trials it is imperative that they be evaluated in institutions where timely and reliable studies can be performed. The important elements of these studies whether they are performed in phase I or early phase II studies include: 1. the collection of complete and accurate clinical information on patients treated. This should include both the monitoring of routine clinical and laboratory parameters as well as for alterations in end organ function suggested by preclinical toxicology or early clinical experience (e.g., cardiac, pulmonary, neurologic); 2. the performance of detailed pharmacologic and pharmacokinetic studies of the new drugs and an attempt to correlate these observations with the important clinical endpoints; 3. the performance, when possible, of studies designed to assess the pharmacodynamic sequelae of the drug in target tissues of interest; and 4. the performance of ancillary laboratory studies which address questions of importance raised by observations made in the clinical trials. Although performance of each of these tasks may require an expertise of its own, it is important that they be considered together. The existence of a group of investigators with a demonstrated ability to perform such studies and with a history of successful collaboration on such projects would identify an institution where new drug development would likely proceed in an efficient and effective manner. This proposal will attempt to demonstrate the capability of the named investigators utilizing the facilities and resources available at the Johns Hopkins Oncology Center and School of Medicine to perform clinical and pharmacologic studies of high quality.