This application seeks support for the activities of CALGB investigators participating through the University of North Carolina at Chapel Hill (UNC-CH) and adjunct institutions in the programs of the Cancer and Leukemia Group B. In this revised application, we demonstrate the growth of the clinical trials and outreach efforts at UNC-CH and its adjuncts, the new scientific and administrative contributions of UNC-CH investigators to Group studies and committees, and the expansion of the UNC-CH accrual effort with the addition of two new adjunct institutions, including the Medical College of Virginia in Richmond and its affiliated Veterans Administration Hospital with the potential to accrue an additional 80-100 patients annually to group studies including all disease sites as well as bone marrow transplantation. Our newly recruited members at UNC-CH have already begun to contribute extensively to the intellectual productivity of the Group by designing and chairing new protocols in Leukemia, Immunology and Genetics, Chemotherapy and Biotherapy, Radiation Therapy, Respiratory and the Breast committees; by presenting pilot observations for group validation and expansion; and by stimulating more basic research components to group activities, particularly in biotherapy, immunology and molecular biology. We plan to continue direct service to the group by maintaining an active Clonal Excess Reference Laboratory that was approved and funded with enthusiasm during the recent review and have added a Biotherapy Monitoring Reference Laboratory at UNC-CH for Group biotherapy studies that received new funding in the last grant review. We have further broadened Group science by the addition of independently funded molecular studies in myelodysplasia in association with Group GM-CSF protocols designed by Edison Liu, a new recruit to our Cancer Center. Previous and new members of our institution will expand our contribution to Group science and administration as core members of standing Group scientific and administrative committees (Ozer, Immunology and Genetics core, Lymphoma core, Chemotherapy core, Chemotherapy vice-chair and Biotherapy chair; Rao, Cytogenetics core; Evans, Psychiatry core; Tepper, Radiation Therapy Core and Gavigan, Data Audit core, Chemotherapy/Biotherapy core, Oncology Nursing core. Newly recruited faculty at UNC-CH will expand our commitment and Group participation in the Breast and Surgery committees (J.Huth,J.Mohler); Radiation Therapy (J.Tepper, J.Rosenman, S.Sailer, J.Raleigh), Cancer Prevention (S.Fletcher) and Psychiatry (D.Evans). Investigators at UNC-CH and its adjuncts have therefore expanded efforts to strengthen the CALGB clinical trials network in the region from Virginia throughout North Carolina and into South Carolina both to increase accrual and to stimulate state-of-the-art quality of oncology care in the region. Ongoing participation in CALGB continues to serve as an important educational vehicle for faculty, fellows and housestaff at UNC-CH as well as the outreach physicians in private practice of hematology and medical oncology who participate in our CALGB activities.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA047559-02
Application #
3558798
Study Section
Cancer Clinical Investigation Review Committee (CCI)
Project Start
1991-06-01
Project End
1993-03-31
Budget Start
1992-05-15
Budget End
1993-03-31
Support Year
2
Fiscal Year
1992
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
Schools of Medicine
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Morrison, Vicki A; McCall, Linda; Muss, Hyman B et al. (2018) The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). J Geriatr Oncol 9:228-234
Li, Megan; Mulkey, Flora; Jiang, Chen et al. (2018) Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension: CALGB 80405 (Alliance). Clin Cancer Res 24:4734-4744
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
Giuliano, Armando E; Ballman, Karla V; McCall, Linda et al. (2017) Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA 318:918-926
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
Himelstein, Andrew L; Foster, Jared C; Khatcheressian, James L et al. (2017) Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA 317:48-58
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
Holstein, Sarah A; Jung, Sin-Ho; Richardson, Paul G et al. (2017) Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol 4:e431-e442
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

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