This is a competitive renewal application on behalf of Case Western Reserve University's (CWRU) Program and its two primary teaching hospitals, Metrohealth Medical Center. (MHMC) and University Hospitals of Cleveland Ireland Cancer Center (UH). The two institutions form one consortium for participation in ECOG activities. The CWRU program has been continuously funded for 24 years. This request describes all the integrated activities of our institution in ECOG; however, the budget relates only to funding for cases in follow-up, travel, study chairs, PI and other secretarial and administrative functions. Compensation for accrual to the trials is through a separate mechanism negotiated between the CTEP staff and Operations office. Our goals are to: 1. Permit the continuation of our participation in ECOG activities, with increased accrual. 2. Continue to provide follow-up. The present follow-up load consists of 743 patients. 3. Continue to maintain and develop additional scientific leadership in different disease committees. The Bone Marrow Transplantation Committee has been chaired, since its inception in ECOG, by Dr. Hillard Lazarus, Future trials include efforts in multiple myeloma and intermediate grade Non-Hodgkin's lymphoma, exploring the use of hematopoietic growth factor-mobilized peripheral blood progenitor cell transplants. 4. Expand our participation in surgically oriented studies that require tumor acquisition, perioperative adjuvant therapy (Ex., E1694/E1695 in melanoma, ES5194 in breast cancer and pharmacokinetic studies through our active surgical oncology division. The PI is a surgical oncologist. 5. Develop Phase III studies in metastatic colorectal carcinoma, using oral 5FU, leuvocorin and 776-C85 (E5296). 6. Extend Group activities of Phase I and II human studies. 7. Develop Phase I studies, either as single institution or multi-institutional, and advance them to randomized clinical trials. 8. Participate in ancillary studies, chemo prevention, cancer control and quality of life protocols. 9. Continue to monitor terminated adjuvant studies, chaired by CWRU investigators, toxicity and prolonged survival (Ex. E1180 Intergroup O11-Adjuvant Therapy in Node Negative Breast Cancer).
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