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Program Director/Principal Investigator (Last, First, Middle): Ochoa, Augusto C. BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Glenn Morris Mills, MD Professor of Medicine MB-CCOP Principal Investigator eRA COMMONS USER NAME (credential, e.g., agency login) gmmills EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) Millsaps College, Jackson, Mississippi University of Mississippi Medical Center, Jackson, MS 05/71 Chemistry MD 12/74 Internal Medicine Tripler Army Medical Center, Honolulu, Hawaii Postdoctor al 06/76 Internal Medicine Brooke Army Medical Center, Fort Sam Houston, TX Fellowship 06/80 Hematology/Oncolog y A. Personal Statement As Director of the Feist-Weiller Cancer Center, Professor and Vice Chairman of the Department of Medicine, Chief of Hematology and Medical Oncology, Director of Clinical Research and Program Director of the Hematology and Medical Oncology fellowship program at LSU Health Sciences Center – Shreveport (LSUHSC-S), I feel I am uniquely qualified to sit on the executive committee and be a site leader for our Shreveport component and sub-components for the Gulf South-Minority Based NCORP (GS-MB-NCORP). The overall goal of the GS-MB-NCORP is to decrease cancer incidence and deaths among the minorities throughout the state of Louisiana through participation in clinical research trials with an emphasis on cancer control and prevention. I have the expertise and experience in clinical research to aide in achieving the goals of the GS-MB-NCORP. I have been the LSUHSC-Shreveport MBCCOP Principal Investigator since the inception of the program in 2007. I have been the SWOG Principal Investigator for LSUSHC-Shreveport since 1986, and our site has received recognition from SWOG as a top accruing minority site as well as for the quality of our data. I have been a member of the Hematology/Oncology faculty at LSUHSC-S since 1986 and Director of Clinical Research at Feist Weiller Cancer Center since 2001. Under my direction and the support and participation of medical hematologist/oncologists, we have been successful in building a clinical research program dedicated to patient enrollment and strict compliance with federal regulatory guidelines. Successful collaboration with a comprehensive multi-disciplinary group of specialists who assist in identifying enrolling, and treating study patients is a major part of the strength and success of our program. I maintain strong ties with other oncologists and physicians in the community, as well as throughout the state, including Dr. Augusto Ochoa. As well, through regular attendance at cooperative group, NCI CCOP, and research base meetings, I have developed good relationships and channels of communication with the leaders in the NCORP program. I feel that by joining forces with the LSUHSC-New Orleans MB-CCOP as well as the Mary Bird Perkins NCI Community Cancer Center Program, we can drastically increase enrollments of our patient population into NCI clinical trials. B. Positions and Honors Positions and Employment 1986-1992 Assistant Professor of Medicine, Section of Hematology/Oncology, LSU School of Medicine, Shreveport, Louisiana 1989–1992 Director, Hematology/Oncology Fellowship Program Feist-Weiller Cancer Center, LSU School of Medicine-Shreveport 7/1992-6/2000 Associate Professor of Medicine, Section of Hematology/Oncology, LSU Health Sciences Center, Shreveport, Louisiana July 1992 – June 2000 PHS 398/2590 (Rev. 06/09) Page 86 Biographical Sketch Format Page Program Director/Principal Investigator (Last, First, Middle): 7/1999-1/2000 7/1999–1/2000 1997 to 2011 1988 – Present 7/2000-Present 4/2001–Present 1995 – 2012 2012 – Present Ochoa, Augusto C. Acting Chief, Hematology/Oncology Section, LSU Health Sciences Center, Shreveport, Louisiana Director, Hematology/Oncology Fellowship Program Feist-Weiller Cancer Center, LSU School of Medicine-Shreveport Associate Director, Feist-Weiller Cancer Center LSU Health Sciences Center, Shreveport, Louisiana Consultant, Hematology/Oncology Service, Overton Brooks VA Medical Center, Shreveport, LA 71101 Professor of Medicine, Section of Hematology/Oncology, LSUHSC-Shreveport, Shreveport, Louisiana Vice Chairman, Department of Medicine LSUHSC-Shreveport, Shreveport, Louisiana Director of Clinical Research, Feist-Weiller Cancer Center LSUHSC-Shreveport Director, Feist-Weiller Cancer Center LSU Health Sciences Center, Shreveport, Louisiana Other Experience and Professional Memberships AOA, 1974 - Present Assistant Investigator, Polycythemia Vera Study Group, New York, New York, 1980 - 1981 Southwest Oncology Group, Principal Investigator 1980 – Present SWOG Committee Memberships: Leukemia Committee, 1980 – Present Leukemia Pathology Review, 1988 - Present Lung Committee, 1986 - Present Quality Assurance Auditor 1982 – Present GI Committee, 1998 to present Head and Neck Committee, 1998 to 2006. Cancer Control Committee, 1998 to present Lymphoma Committee, 1985 – 2002 Member, American Association for the Advancement of Science, 1980 - Present Member, American Society of Hematology, 1981 - Present Member, American Federation for Clinical Research 1981 - Present President, San Antonio Blood Club, 1985 Member, American Society of Clinical Oncology, 1986 - Present Member, Southern Medical Association, 1988 - Present Member, Southern Oncology Association, 1988 - Present Member, Louisiana State Medical Society, 1992 – Present Member, Caddo Parish Medical Society, 1992 – Present Member AMA, 1992 to present. Member, Association of Program Directors in Internal Medicine, 1992-1997 Member, American Association of Cancer Research, 1994-Present Member, Association of Patient Oriented Research, 2000 Member, Association of Subspecialty Professors of Medicine, 1999 to present. Member, International Society of Lung Cancer, 1999 to present. Member Association of Community Cancer Centers, 1999 to present. Member NCI Clinical Trials Support Unit, 2000 Member ACGME Residency Review Committee in Internal Medicine Appointed 1/1/2003-present; Executive Committee 2004 - present Member, Coalition For a Tobacco Free Louisiana, 2002 to present Medical Director, Northwest Louisiana Tumor Registry, 1987 – 1988 & 1999 to 2001 Member, Louisiana State Hemophilia Advisory Committee, 1989 - 1992 Board of Directors, Northwest Louisiana Chapter of the American Cancer Society, 1990 - 1992 Member, Louisiana Lung and Cancer Trust Fund Board, 1990 - 1995 Treasurer, Louisiana Lung and Cancer Trust Fund Board, 1992 - 1995 Grant Review Committee for LSUMC-NO Center for Excellence in Cancer, 1995 PHS 398/2590 (Rev. 06/09) Page 87 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Ochoa, Augusto C. C. Selected Peer-reviewed Publications 1. Adelstein DJ, Moon J, Hanna E, Giri PG, Mills GM, Wolf GT, Urba SG. Docetaxel, cisplatin, and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous cell head and neck cancer: A Southwest Oncology Group phase II trial (S0216). Head Neck. 2010 Feb;32(2):221-8. 2. Sequist LV, Fidias PM, Temel JS, Kolevska T, Rabin MS, Boccia RV, Burris HA, Belt RJ, Huberman MS, Melnyk O, Mills GM, Englund CW, Caldwell DC, Keck JG, Meng L, Jones M, Brown GL, Edelman MJ, Lynch TJ. Phase 1-2a multicenter dose-ranging study of canfosfamide in combination with carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer. J Thorac Oncol. 2009 Nov;4(11):1389-96. 3. Ampil F, Sangster G, Mills G, Nathan CO, Lian T, Hall A. Radiologic findings after successful chemoradiation for nasopharyngeal cancer with skull base erosion. Ear Nose Throat J. 2010 Jan;89(1):38-41. 4. Ekshyyan O, Mills GM, Lian T, Amirghahari N, Rong X, Lowery-Nordberg M, Abreo F, Veillon DM, Caldito G, Speicher L, Glass J, Nathan CO. Pharmacodynamic evaluation of temsirolimus in patients with newly diagnosed advanced-stage head and neck squamous cell carcinoma. Head Neck. 2010 Dec;32(12):1619-28. 5. Peddi P, Slay LE, Lilien DL, Fowler MR, Cotelingam J, Veillon DM, Ayirookuzhi S, Koshy N, Mills GM, Munker R. Metastatic malignant melanoma in a patient with Hodgkin's lymphoma in remission. J La State Med Soc. 2010 Jan-Feb;162(1):47-50. 6. Chu DZ, Hussey MA, Alberts DS, Meyskens FL Jr, Fenoglio-Preiser CM, Rivkin SE, Mills GM, Giguere JK, Blanke CD, Goodman GE. Colorectal Chemoprevention Pilot Study (SWOG-9041), randomized and placebo controlled: the importance of multiple luminal lesions. Clin Colorectal Cancer. 2011 Dec;10(4):310-6. 7. Armaghany T, Wilson JD, Chu Q, Mills G. Genetic alterations in colorectal cancer. Gastrointest Cancer Res. 2012 Jan;5(1):19-27. PMC3348713. 8. Ampil FL, Caldito G, Mills G, Marion J, Balandin A, Ponugupati J. Short survival after palliative radiotherapy for brain metastases in lung cancer: does the end justify the means? Am J Hosp Palliat Care. 2013 Jun;30(4):331-3. 9. Ampil F, Caldito G, Mills G, Takalkar A, Ghali G, Kim D. Chemoradiotherapy for unresectable stage IVB head and neck cancer. J La State Med Soc. 2012 Sep-Oct;164(5):260-4. 10. Jafri SH, Mills G. Lifestyle modification in colorectal cancer patients: an integrative oncology approach. Future Oncol. 2013 Feb;9(2):207-18. 11. Ampil F, Chaudhery S, Devarakonda S, Mills G. Extended survival after chemotherapy and conservative radiotherapy for HPV-16 positive stage IVB oropharyngeal carcinoma. Acta Oncol. 2013 Aug;52(6):1236-7. 12. Jafri SH, Shi R, Mills G. Advance lung cancer inflammation index (ALI) at diagnosis is a prognostic marker in patients with metastatic non-small cell lung cancer (NSCLC): a retrospective review. BMC Cancer. 2013 Mar 27;13:158. PMC3618002. 13. Eberhardt WE, Mitchell P, Schiller JH, Brown MP, Thomas M, Mills G, Jehl V, Urva SR, De Leo JJ, Gogov S, Papadimitrakopoulou V. Feasibility of adding everolimus to carboplatin and paclitaxel, with or without bevacizumab, for treatment-naive, advanced non-small cell lung cancer. Invest New Drugs. 2013 Apr 12. [Epub ahead of print] 14. Shi R, Mills G, McLarty J, Burton G, Shi Z, Glass J. Commercial insurance triples chances of breast cancer survival in a public hospital. Breast J. 2013 Nov-Dec;19(6):664-7. [PubMed - in process] 15. Stiff PJ, Unger JM, Cook JR, Constine LS, Couban S, Stewart DA, Shea TC, Porcu P, Winter JN, Kahl BS, Miller TP, Tubbs RR, Marcellus D, Friedberg JW, Barton KP, Mills GM, LeBlanc M, Rimsza LM, PHS 398/2590 (Rev. 06/09) Page 88 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Ochoa, Augusto C. Forman SJ, Fisher RI. Autologous transplantation as consolidation for aggressive non-Hodgkin's lymphoma. N Engl J Med. 2013 Oct 31;369(18):1681-90. D. Research Support GLENN M. MILLS, MD ACTIVE U10CA128567 08/01/2007-05/31/2015 NIH-NCI LSUHSC-Shreveport Feist Weiller Cancer Center MBCCOP The Feist-Weiller Cancer Center (FWCC) Minority-Based Community Clinical Oncology Program (MB-CCOP) aims to provide increased access to state-of-the-art cancer prevention care, and control through NCIsponsored clinical trials to the minority and indigent populations in the northwestern section of La., and throughout the state of Louisiana. Role: Principal Investigator Cephalon – Protocol #C18083/3064/NL/MN 08/2009 – 03/2017 CEPHALON Oncology An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cuyclopyosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) The major goal of this project is to compare the complete response rate of bendamustine and rituximab with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine and prednisone, or rituximab, cyclosphosphamide, doxorubicin, vincristine, and prednisone in the first-line treatment of patients with advanced indolent NHL or mantle cell lymphoma on the basis of a non-inferiority margin of 15%. Panorama 1 – Protocol #CLBH589D2308 12/2009 – 06/2014 NOVARTIS A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Panobinostat in Combination with Bortezomib and Dexamethasone in Patients with Relapsed Multiple Myeloma. It is the purpose of this study to compare treatment with BTZ/Dex + PAN to BTZ/Dex + Placebo in patients with previously treatment MM whose disease has recurred or progressed. Progression free survival is the primary endpoint of the study. Completed Research Support Wyeth 3066KI-404-WW 02/25/2008 – 03/01/2012 WYETH Pharmaceuticals “A Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients with Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy” The major goals of this project are to compare the efficacy, safety and tolerability of temsirolimus and sorafenib when used as single agents in the second-line setting in subjects with advanced RCC who have failed first-line treatment with sunitinib. Amgen 20062088 11/26/2007 – 12/01/2012 AMGEN Pharmaceutical Co. “Phase II, Single-Arm, Open-Label, Multi-center Trial of Second-Line Panitumumab Monotherapy in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck” The major goal of this project is to estimate the effect of second-line panitumumab monotherapy on objective response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and PHS 398/2590 (Rev. 06/09) Page 89 Continuation Format Page Program Director/Principal Investigator (Last, First, Middle): Ochoa, Augusto C. neck. Time to response, duration of response, rate of disease control, time to progression, PFS, and OS will also be assessed. PHS 398/2590 (Rev. 06/09) Page 90 Continuation Format Page