The overall objective of this project is to provide support for performance of clinical studies of the Cancer and Leukemia Group B at the Lombardi Cancer Center at Georgetown University Medical School. The LCC/GUMC is an NCI-designated Comprehensive Cancer Center. In 1988, Marc Lippman, M.D., assumed Directorship of the Lombardi Cancer Center. Under his direction, the Cancer Center was designated as a Federally Funded Cancer Center in 1989. The Cancer Center became a Federal designated """"""""Comprehensive Cancer Center"""""""" in 1992, and the Cancer Center Support Grant was renewed in 1996 with an overall rating of """"""""excellent to outstanding."""""""" During the previous funding period, LCC/GUMC has participated in CALGB studies as an unfunded affiliate institution of the University of Maryland Cancer Center. In March, 1997, the CALGB Board of Directors approved LCC/GUMC as a Main Member Institution. At that time, Dr. Daniel F. Hayes was named as Institutional Principal Investigator. LCC/GUMC will participate in the entire range of multimodatity clinical studies, including both therapeutic studies, correlative science studies. and companion studies of quality of life, survivorship, and cost effectiveness analyses. LCC faculty have been active in all three areas of CALGB activities: accrual, scientific leadership, and administrative tasks. As of May 1, 1997, 41 CALGB protocols were active at LCC/GUMC. A total of 129 patients have entered CALGB studies since LCC entered CALGB in 1990, with 78 of these during this funding period (1993-1996). Accrual has increased over the last three years: 1994, 10 patients; 1995, 26 patients, and 1996, 31 patients. 17 percent of these patients were from minority populations, and 69 percent of patients entered onto CALGB trials were women. A recent audit by CALGB rated LCC as """"""""Acceptable."""""""" Several initiative are being used to increase accrual at LCC, including recruitment of onsite clinical faculty committed to clinical trials, organization of a highly coordinated Clinical Research Management Office, development of a clinical Research Consortium of off-site affiliates. and development of a Patient Accession Core Project. Lombardi has a major program to increase accrual of minorities and women to clinical trials, coordinated by the Associate Director of the Cancer Center, Dr. John Kemer. It is estimated that LCC will accrue 95 patients/year to CALCB therapeutic and companion studies. LCC faculty are already leaders in CALGB, with 12 cadre committee members, two of whom are Committee Chairs (Dr. Hayes, Solid Tumor Correlative Science; Dr. Raymond Weiss, Audit). Five faculty members are Study Chairs for 11 active CALGB trials or companion studies. Two faculty have two concepts under review that are likely to open in the next twelve months. Because of the depth of scientific accomplishments of the LCC faculty, it is anticipated that many more will assume leadership roles within CALGB now that LCC/GUMC has Main Member Status. Three faculty have had administrative roles, including Dr. Raymond Weiss who started and has been the only Chair of the Audit Committee. The LCC research infrastructure for clinical and translational science is substantial, and LCC faculty are expected to provide leadership in developing clinical and correlative science studies during the next funding cycle. In summary, with Main Membership status and maturation of the Cancer Center, the LCC is expected to become one of the leading institutions within the CALGB during the next five years.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Study Section
Subcommittee G - Education (NCI)
Program Officer
Mooney, Margaret M
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Georgetown University
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United States
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Straus, David J; Jung, Sin-Ho; Pitcher, Brandelyn et al. (2018) CALGB 50604: risk-adapted treatment of nonbulky early-stage Hodgkin lymphoma based on interim PET. Blood 132:1013-1021
Campbell, Jeffrey I; Yau, Christina; Krass, Polina et al. (2017) Comparison of residual cancer burden, American Joint Committee on Cancer staging and pathologic complete response in breast cancer after neoadjuvant chemotherapy: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 165:181-191
Mandelblatt, Jeanne S; Cai, Ling; Luta, George et al. (2017) Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance). Breast Cancer Res Treat 164:107-117
Freedman, Rachel A; Foster, Jared C; Seisler, Drew K et al. (2017) Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. J Clin Oncol 35:421-431
Kimmick, Gretchen G; Major, Brittny; Clapp, Jonathan et al. (2017) Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503). Breast Cancer Res Treat 163:391-398
Martin, P; Jung, S-H; Pitcher, B et al. (2017) A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance). Ann Oncol 28:2806-2812
Smith, Sonali M; Pitcher, Brandelyn N; Jung, Sin-Ho et al. (2017) Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials. Lancet Haematol 4:e176-e182
Freedman, Rachel A; Seisler, D K; Foster, J C et al. (2017) Risk of acute myeloid leukemia and myelodysplastic syndrome among older women receiving anthracycline-based adjuvant chemotherapy for breast cancer on Modern Cooperative Group Trials (Alliance A151511). Breast Cancer Res Treat 161:363-373
Bluethmann, Shirley M; Alfano, Catherine M; Clapp, Jonathan D et al. (2017) Cognitive function and discontinuation of adjuvant hormonal therapy in older breast cancer survivors: CALGB 369901 (Alliance). Breast Cancer Res Treat 165:677-686
Dickson, M A; Mahoney, M R; Tap, W D et al. (2016) Phase II study of MLN8237 (Alisertib) in advanced/metastatic sarcoma. Ann Oncol 27:1855-60

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