CANCER AND LEUKEMIA GROUP B

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Duke Medical Center is currently completing its first 5 year grant cycle as a member of Cancer and Leukemia Group B (CALGB). During this time period, Duke has consistently been one of the top five institutions in overall patient accrual, and has been the leading institution in patient accrual from a main member institution. Duke is currently developing an affiliate program which will lead to a substantial increase in patient accrual. Both intramural and extramural clinical trials are coordinated through a central protocol office at Duke. This office provides core administrative support and quality assurance for a large group of research nurses and data managers who coordinate clinical trials on a disease and modality specific basis. This organizational structure is further strengthened by close interaction with the CALGB biostatistics and data management center at Duke under the direction of Dr. Stephen George, who is also Director of Biostatistics for the Duke Cancer Center. Scientifically, Duke has active cadre members on all the disease and modality related CALGB committees. Currently, 12 investigators at Duke are involved in ongoing or planned CALGB trials. Duke investigators serve as study chairs on the pending randomized Phase III trial for patients with AML less than 60, the randomized Phase III trial of dose intensified CHOPE chemotherapy with colony stimulating factor support in non Hodgkins lymphoma, the major national randomized trial of high dose chemotherapy with autologous bone marrow support in the adjuvant treatment of breast cancer, the pending trial of Taxol in StageIII breast cancer patients, a number of respiratory cancer and GU cancer trials. In addition, Duke has been a center for Phase I trials for the pharmacology and experimental therapeutics and has been a leading center for psycho-oncology. Multi modality. support has also been provided by active participation from surgical oncology, radiation oncology, Pathology and correlative sciences. In addition, Duke has been a major contributor to minority patient accrual and high priority trials. Areas of expansion by Duke investigators within the CALGB over the next grant cycle will involve cancer control, cancer treatment cost analysis, and gero-oncology. As a leading institution in CALGB activities during our initial grant cycle, Duke is looking forward to funding support appropriate to our current and anticipated level of patient accrual and scientific involvement in CALGB trials during the next grant cycle.