PHASE I CLINICAL TRIAL OF ANTICANCER AGENTS

将新型抗肿瘤药物引入临床试验残留物 临床肿瘤学中最重要的研究领域之一。至 确保患者的护理和治疗继续取得进展 似乎可以肯定的是，调查人员将需要在 现有的治疗方法部分是通过引入新的药物来实现的 并在这些项目中引入新的模式。为了让这些代理人取得进展 顺利通过早期临床试验是当务之急 在可以进行及时和可靠研究的机构进行评估 已执行。这些研究的重要元素无论是 在第一阶段或第二阶段早期进行的研究包括： 1.收集完整及准确的临床资料 接受治疗的病人。这应该包括对例行程序的监测 临床和实验室指标以及终末器官的改变 临床前毒理学或早期临床经验提示的功能 (例如，心脏、肺、神经)； 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 重要的临床终点； 3.在可能的情况下，旨在评估 药物在目标组织中的药效学后遗症；以及 4.辅助实验室研究的绩效，这些研究涉及 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可能需要以下专业知识 就其自身而言，重要的是将它们放在一起考虑。他的存在 一群被证明有能力这样做的调查人员 研究并在此类项目上有成功合作的历史 将确定一家机构，在那里新药开发可能 以高效和有效的方式进行。 这项提案将试图展示指定的 调查人员利用现有设施和资源 约翰霍普金斯大学肿瘤中心和医学院将进行临床 和高质量的药理研究。

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.