The Bowman Gray School of Medicine is a major contributor to CALGB protocols. Accrual to protocol studies is enhanced by the Piedmont Oncology Association (POA), our Satellite Center at the University of South Carolina, and established referral patterns of the North Carolina Baptist Hospital based on our excellence in patient care. Bowman Gray faculty are currently chairmen of 4 protocol studies and participate in numerous other CALGB activities. Clinical support for these studies is provided by nine full-time oncologists, two gynecological oncologists, four radiation therapists, three pathologists, and one surgical oncologist.
The specific aims are as follows: 1) To investigate new treatments and participate in the development of improved clinical protocols for neoplastic disease. 2) To develop local and CALGB pilot studies which lead to improved treatments tested in CALGB phase II and III studies. 3) To develop improved techniques of data capture and a query system to improve protocol compliance and the quality of data collection. 4) To complete the analysis of CALGB protocol #7761 (A Study to Determine the Effectiveness of Single Versus Multiple Alkylating Agents with and without Adriamycin in the Primary Treatment of Multiple Myeloma). 5) To complete a manuscript analyzing the effects of age and prior treatment on the frequency and duration of complete remission as related to various four-drug treatments for advanced Hodgkin's disease (CALGB protocol #7251). 6) To develop a program for diffuse histiocytic lymphoma employing a """"""""kinetic modeling format"""""""" testing the theoretic benefits of both Norton-Simon and Goldie-Coleman. 7) To develop a phase II clinical trial of alpha2 interferon testing its effectiveness in good risk myeloma patients and those patients with myeloma who show progression of their disease after treatment with standard therapy. 8) To complete a clinical and pharmacological study of sequential high-dose ARA-C (HiDAC) and asparaginase (ASNase) for remission induction and post-remission intensification in patients with acute leukemia. 9) To conduct a study on the pharmacokinetics of ARA-C in patients with acute non-lymphocytic leukemia (protocol #8221).

National Institute of Health (NIH)
National Cancer Institute (NCI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Cancer Clinical Investigation Review Committee (CCI)
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Wake Forest University Health Sciences
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Gajra, Ajeet; McCall, Linda; Muss, Hyman B et al. (2018) The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance). J Geriatr Oncol 9:221-227
Vasu, Sumithira; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) Ten-year outcome of patients with acute myeloid leukemia not treated with allogeneic transplantation in first complete remission. Blood Adv 2:1645-1650
Eisfeld, Ann-Kathrin; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) Mutation patterns identify adult patients with de novo acute myeloid leukemia aged 60 years or older who respond favorably to standard chemotherapy: an analysis of Alliance studies. Leukemia 32:1338-1348
Eisfeld, Ann-Kathrin; Kohlschmidt, Jessica; Mrózek, Krzysztof et al. (2018) NF1 mutations are recurrent in adult acute myeloid leukemia and confer poor outcome. Leukemia 32:2536-2545
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
Basch, Ethan; Dueck, Amylou C; Rogak, Lauren J et al. (2017) Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials. JAMA Oncol 3:1043-1050
Uy, Geoffrey L; Mandrekar, Sumithra J; Laumann, Kristina et al. (2017) A phase 2 study incorporating sorafenib into the chemotherapy for older adults with FLT3-mutated acute myeloid leukemia: CALGB 11001. Blood Adv 1:331-340
Cushman, Stephanie M; Jiang, Chen; Hatch, Ace J et al. (2015) Gene expression markers of efficacy and resistance to cetuximab treatment in metastatic colorectal cancer: results from CALGB 80203 (Alliance). Clin Cancer Res 21:1078-86
Morrison, Vicki A; Jung, Sin-Ho; Johnson, Jeffrey et al. (2015) Therapy with bortezomib plus lenalidomide for relapsed/refractory mantle cell lymphoma: final results of a phase II trial (CALGB 50501). Leuk Lymphoma 56:958-64
Voorhees, Peter M; Orlowski, Robert Z; Mulkey, Flora et al. (2015) Long-term outcomes for newly-diagnosed multiple myeloma patients treated with pegylated liposomal doxorubicin and bortezomib: final results of CALGB (Alliance) 10301, a multicentre phase II study. Br J Haematol 171:373-7

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