PHASE I CLINICAL TRIAL OF ANTICANCER AGENTS

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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.