UNIVERSITY OF IOWA INSTITUTIONAL CALGB GRANT

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This application is to support our participation in the multi- disciplinary and multi-institutional cooperative group clinical trials of Cancer and Acute Leukemia Group B. Since joining the CALGB 6 months ago, we have developed into active participants in both phase 2 and 3 studies and companion studies emphasizing laboratory investigation. The multidisciplinary studies of the group assist in bringing together these modalities at the University of Iowa itself. Cooperative group membership allows the University of Iowa investigators over the next 5 years to focus on innovative, small clinical trials (Phase 1/2 type trials appropriate for a single institution) while participating in controlled, randomized phase III trials not feasible within a single hospital. Further, the activities of the CALGB have initiated research at the University of Iowa utilizing biological response modifiers in a setting in which controlled comparisons can be made. Our specific goals in the next grant period include initiating for the group trials in salvage therapy for Hodgkin's and non-Hodgkin's lymphoma patients resistant to lst line therapies using intensive therapy and autologous bone marrow transplant support, trials using the immunology laboratory of the University of Iowa for assay of LAK cell activity and other immunologic parameters, trials using radiation sensitizers (such as Lonidamine) or endobronchial radiation as innovations in radiation therapy, and trials using differentiating agents (13-cis Retinoic Acid, Vitamin D3) based on phase I/II trial results at the University of Iowa. Through participation in groups trials we hope to advance the programs of the entire CALGB. Through pilot studies (such as MOPLEC for Hodgkin's disease or beta-Interferon and IL-2 for lymphoma) we will help develop newer therapies for future controlled trials. Through laboratory related companion studies, we will advance the basic science programs of other CALGB institutions. The multi- disciplinary programs of the CALGB will contribute over the next 5 years to the training of both fellows and residents at the University of Iowa. Through the development of 3 affiliate programs, quality multidisciplinary cancer care will be fostered in Iowa, a rural state with few large cancer programs. Our accrual should be approximately 100 patients per year from the University of Iowa Hospital system and 20 more patients in addition per year from our 3 affiliates.