This research plan outlines the institutional efforts at Duke to implement and complete existing clinical trials in cancer patients and develop new trials as part of a cooperative group effort within the Cancer and Leukemia Group B (CALGB). The clinical success of such cooperative group protocols depend on several factors including physician orientation and enthusiasm, an adequately large patient population, and an organizational structure that facilitates the proper implementation and adherence to such studies. Equally important is a data management system that provides timely and accurate reporting of outcome. The Duke Cancer Center has a long history of physician participation in cooperative group trials and is fortunate to have an organized network of data managers, nurse clinicians, research analysts, and administrative personnel. This structure has resulted in Duke being one of the leading institutions in CALGB protocol participation within a matter of months. The scientific success of cooperative group trials depends upon the eagerness for physicians to explore new ideas and to work collaboratively between disciplines to develop new strageties. Duke is fortunate to have active multi-disciplinary working groups that overlap clinical and basic sciences in all the major areas of cancer treatment. These groups will be a valuable resource for future scientific direction within the CALBG. Duke investigators have already developed three trials that demonstrate our institutional focus on biologically oriented clinical cancer trials: 1)bone marrow transplantation in an adjuvant setting in breast cancer patients with 10 or more positive lymph nodes, 2) investigation of gamma interferon therapy in a phase II trial of previously untreated non-small cell lung cancer patients, accompanied by detailed immunomodulatory studies to document the dose response relationship between the biological effect of gamma interferon and treatment outcome and, 3) the role of continuous infusion Ara-C in the management of chronic granulocytic leukemia. This protocol was developed from in vitro studies of the enhanced effect of Ara-C on leukemic vs. normal granulocytes as well as pilot clinical data developed at Duke. Thus, Duke's involvement in CALGB will result in a major increase in patient accrual to group studies as well as the development of new and innovative trials in a cooperative group setting.
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