Program Director/Principal Investigator (Last, First, Middle): Muller, Carolyn
BIOGRAPHICAL SKETCH
Provide the following information for the 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
Carolyn Y. Muller, M.D. / POSITION TITLE
Professor
Director, Division of Gynecologic Oncology
eRA COMMONS USER NAME (credential, e.g., agency login) CAROLYNMULLER
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training and residency if applicable.)
INSTITUTION AND LOCATION / DEGREE
(if applicable) / MM/YY / FIELD OF STUDY
Lafayette College, Easton, PA / B.A. / 1984 / Chemistry
University of Pennsylvania, Philadelphia, PA / M.D. / 1988 / Medicine
Pennsylvania Hospital, Philadelphia, PA / Residency / 1988-1992 / Gynecology/Obstetrics
UT Southwestern Medical Center, Dallas, TX / Fellowship / 1993-1996 / Gynecologic Oncology
UT Southwestern Medical Center, Dallas, TX / Postdoctoral Fellowship / 1996-1998 / Molecular Biology
PHS 398/2590 (Rev. 06/09) Continuation Format Page
Program Director/Principal Investigator (Last, First, Middle): Muller, Carolyn
A. Personal Statement
I am Chief of Gynecologic Oncology at the University of New Mexico and a full member of the NIH designated Cancer Center. I am the site PI of the Gynecologic Oncology Group grant and serve as the local PI for a large number of GOG clinical trials as well as other pharmaceutical trials and investigator initiated trials with the bulk of these trials in ovarian cancer. I am a trained physician-scientist who has served as scientific reviewer for the NIH in the SBIR/STTR and CONC study sections as well as the Department of Defense (DOD) for their ovarian cancer grant program. I also serve as Chair of the Data Safety Monitoring Committee (DSMC) for our center’s clinical trials office and chief of the Gynecologic Cancer Clinical Working Group. Since coming to New Mexico in 2004, my research focus has been in ovarian cancer. I have collaborations with basic scientists at UNM investigating novel or repurposed drug compounds active against Rho-family GTPases that have in vitro inhibition of cell growth, and migration in ovarian cancer cells. My collaborations emphasize preclinical and clinical studies needed to move the drugs forward. I have extended this work into an epidemiologic outcome study looking at outcomes in ovarian cancer patients exposed to the drug of interest.
B. Positions and Honors
Professional Appointments
07/93 - 06/96 / Assistant Instructor of Obstetrics and Gynecology, University of Texas Southwestern Medical School, Dallas, TX07/93 - 06/96 / Fellowship in Gynecologic Oncology, Department of Obstetrics and Gynecology and Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX
07/96 – 8/02 / Assistant Professor of Obstetrics and Gynecology, University of Texas Southwestern Medical School, Dallas, TX
8/02 – 11/04 / Associate Professor of Obstetrics and Gynecology, University of Texas Southwestern Medical School, Dallas, TX
11/04 – 7/09 / Associate Professor, Director, Division of Gynecology Oncology, Granted Tenure on July 1, 2006 University of New Mexico Health Sciences Center, Albuquerque, NM
7/09 - Present / Professor with Tenure, Director, Division of Gynecology Oncology, University of New Mexico Health Sciences Center, Albuquerque, NM
Honors and Awards
2003 / James F. Nolan Award, May 26-29, 2004 Western Association of Gynecologic Oncologists Annual Meeting, Monterey, CA2000 / National Cancer Institute’s EDRN (Early Detection Research Network), Associate Member
2000 / American Airlines Young Investigator Award
1999-2001 / Mary Kay Ash Foundation Award
1998-2001 / RSDP/Burroughs Welcome Award, The Cancer Research Foundation of North Texas, Cancer Research
1996-1998 / AAOGF Reproductive Scientist Development Program Fellow
1994-1995 / American Cancer Society, Clinical Oncology Fellow
1992 / The Doctor Thomas V. Zachary, III Award recipient, Pennsylvania Hospital
1992 / John M. Riva, M.D. Resident Award in Gyn Oncology recipient, Pennsylvania Hospital
Scientific Reviewer or Editorial Duties for Journals
Clinical Cancer Research, Associate Editor, Member of Editorial Board, 2006-2012
Gynecologic Oncology , Member of Editorial Board, 2006-2007, Reviewer 1997-Present
Peer reviewer for 19 journals (select: Journal of National Cancer Institute, International Journal of Gynecologic Cancer, British Journal of Cancer, Cancer Epidemiology Biomarkers Prevention, International Journal of Cancer)
Study Section Scientific Reviewer
National Institutes of Health, Center for Scientific Review, Special Study Section SBIR/STTR: Cancer Diagnostics, Treatment, 2003, 2005, 2006, 2007, 2008-Present; Clinical Oncology (CONC) Ad Hoc reviewer, 2007-2011, Full member: 07/11-Present, NIH Loan Repayment Program 2007-Present
Department of Defense, US Army Medical Research and Material Command, Congressional Directed Research Programs for Ovarian Cancer Research Program, 1999, 2000, 2003-2006, 2009, 2010-Present; Concept Award: 2007
Department of Defense, US Army Medical Research and Material Command, Congressional Directed Research Programs for Breast Cancer Research Program 2003, 2007, 2008
Current Professional Memberships
Full Member: American College of Obstetrics and Gynecology, American Board of Obstetrics & Gynecology, American Association of Cancer Research, American Society of Clinical Oncology, International Gynecologic Cancer Society, Society of Gynecologic Investigation, Society of Gynecologic Oncology,
C. Selected Peer-reviewed publications (In chronological order)
Publications
Peer Review Articles
1. Castle PE, Ashfaq R, Ansari F, Muller CY. Immunohistochemical evaluation of heat shock proteins in normal and preinvasive lesions of the cervix. Cancer Lett. 2005 Nov 18;229(2):245-52. Epub 2005 Aug 19.
2. Muller CY, Schorge JO, Tomlinson GE, Ashfaq R. BRCAPAP: feasibility of clinical BRCA testing on liquid-based cervical cytology: implications for biomarker development. Cancer Epidemiol Biomarkers Prev. 2004 Sep;13(9):1534-7.
3. Lea JS, Ashfaq R, Muneer S, Burbee DG, Miller DS, Minna JD, Muller CY. Understanding the mechanisms of FHIT inactivation in cervical cancer for biomarker development. J Soc Gynecol Investig. 2004 Jul;11(5):329-37.
4. Cole LA, Butler SA, Khanlian SA, Giddings A, Muller CY, Seckl MJ, Kohorn EI.
Gestational trophoblastic diseases: 2. Hyperglycosylated hCG as a reliable marker of active neoplasia. Gynecol Oncol. 2006 Aug;102(2):151-9. Epub 2006 May 2.
5. Lea JS, Sunaga N, Sato M, Kalahasti G, Miller DS, Minna JD, Muller CY. Silencing of HPV 18 oncoproteins With RNA interference causes growth inhibition of cervical cancer cells. Reprod Sci. 2007 Jan;14(1):20-8.
6. Cole LA, Khanlian SA, Sasaki Y, Muller CY. Normal Production of hCG in Menopause: A Medical Management Dilemma. New England Journal of Medicine. 2007; 356(11):1184-6.
7. Arias-Pulido H, Joste N, Chavez A, Muller CY, Dai D, Smith HO, Verschraegen CF. Absence of epidermal growth factor receptor mutations in cervical cancer. Int J Gynecol Cancer 2008; 18(4):749-54.
8. Muller CY, Khalian SA, Butler SA, Cole LA. The Quagmire hCG and hCG Testing in Gynecological Oncology. Gynecol Oncol 2009 March, 112(3):663-72.
9. Rivkin SE, Muller CY, Moon J, Iriarte D, Arthur J, Gerould H Malmgren JA.A Phase I/II Study of Lapatinib plus Carboplatin and Paclitaxel In Stage III/IV Relapsed Ovarian Cancer. Journal of Clinical Oncology. 2009 November: (2) 2: 112-117.
11. K De Geest, JA Blessing, RT Morris, SD Yamada, BJ Monk, SL Zweizig, D Matei, CY Muller, and WE Richards. A phase II clinical trial of ixabepilone (BMS-247550) in patients with recurrent or persistent platinum and taxane resistant ovarian or primary peritoneal cancer: A Gynecologic Oncology Group Study. J Clin Oncol 2010 Jan, 116(1):3-9.
12. Zeineldine R, Muller CY, Stack MS, Hudson LG. Targeting the EGF receptor for ovarian cancer therapy. J Oncol. 2010; 2010:414676.
13. RJ Schilder, JA Blessing, MS Shahin, DS Miller, KS Tewari, CY Muller, D Warshal, DS McMeekin, J Rotmensch. A phase II evaluation of Irofulven (IND#55804, NSC#683863) in the treatment of recurrent or persistent platinum-sensitive ovarian or primary peritoneal cancer: A Gynecologic Oncology Group trial" International Journal of Gynecological Cancer. 2010 Oct; 20(7):1137-41.
14. CF Verschraegen, H Arias-Pulido, SJ Lee, S Movva, LA Cerilli, S Eberhardt, B Schmit, R Quinn, CY Muller, I Rabinowitz, M Purdy, D Snyder, T Bocklage. Phase IB study of the combination of docetaxel, gemcitabine, and bevacizumab in patients with advanced or recurrent soft tissue sarcoma: the Axtell regimen. Ann Oncol. 2011 Jul 11.
15. TI Oprea, JE Bauman, CG Bologa, CY Muller et al. Drug repurposing from an academic perspective. Drug Discoveries Today: Thera Strat. Winter 2011; 8(3-4): 61-69
16. T Soonthornthum, H Arias-Pulido, N Joste, CY Muller, T Rutledge, C Verschraegen. Epidermal growth factor receptor as a biomarker for cervical cancer. Ann Oncol. 2011 Oct; 22(10):2166-78
17. BJ Monk, JA Blessing, DG Street, CY Muller, JJ Burke, ML Hensley. A phase II evaluation of trabectedin in the treatment of advanced, persistent, or recurrent uterine leiomyosarcoma: a gynecologic oncology group study. Gynecol Oncol. 2012 Jan; 124(1):48-52.
18. J Bauman, C Verschraegen, S Belinsky, CY Muller, T Rutledge, M Fekrazad, M Ravindranathan, SJ Lee, D Jones. A phase I study of 5-azacytidine and erlotnib in advanced solid tumor malingnancies. Cancer Chemother Pharmacol. 2012 Feb; 69(2):547-54
19. Verschraegen CF, Arias-Pulido H, Lee SJ, Movva S, Cerilli LA, Eberhardt S, Schmit B, Quinn R, Muller CY, Rabinowitz I, Purdy M, Snyder D, Bocklage T. Phase IB study of the combination of docetaxel, gemcitabine, and bevacizumab in patients with advanced or recurrent soft tissue sarcoma: the Axtell regimen. Ann Oncol. 2012 Mar; 23(3): 785-90
20. Verschraegen CF, Czok S, Muller CY, Boyd L, Lee SJ, Rutledge T, Blank S, Pothuri B, Eberhardt S, Muggia F. Phase II study of bevacizumab with liposomal doxorubicin for patients with platinum- and taxane-resistant ovarian cancer. Ann Oncol. 2012 Dec;23(12):3104-10
21. Cook LS, Nelson HE, Cockburn M, Olson SH, Muller CY, Wiggins CL. Comorbidities and endometrial cancer survival in Hispanics and non-Hispanic whites. Cancer Causes Control. 2013 Jan;24(1):61-9.
D. Research Support
ACTIVE
DOD OC110514 Muller, CY (Co-Investigator) 7/1/12-6/30/15
Ovarian Cancer Research Program Teal Expansion Award
Inhibition of small GTPases as a novel therapeutic approach in ovarian cancer
The objective of this project is to determine mechanisms of GTPase inhibition by R-ketorolac and conduct a pilot clinical trial
#27469-64 Muller, CY (PI) 4/1/10-3/31/16
Gynecologic Oncology Group Grant - Clinical Trials
GOG has obtained funding to conduct clinical trial relating to gynecologic oncology (“Clinical Trail(s)”) through the
National Institute of Health (“NIH”), National Cancer Institute (“NCI”) or other body, or such funding has been earmarked to GOG for the Study.
NIH NCI, R01 CA119232 Muller, CY (Co-Investigator) (PI Wilson) 7/1/05-6/31/13
“MSM Mapping and Modeling ErbB Receptor Membrane Topography”
This project is aligned with the IMAG/MSM program; it involves quantitative measurements and mathematical modeling of membrane signaling proteins, then extends to tumor modeling based upon data from xenografts
NCI S09-148 Muller, CY (Investigator), (PI: Bocklage) 3/1/11-8/30/15
Biospecimen Contributing Institutions for Research Studies in Cancer Tissue Pre-Analytical Variables
This NCI contract is for a scientifically extreme annotation of surgical material to determine the effect of surgical effect on the molecular changes in normal and tumor cells. Ovarian and endometrial cancer and normal collection are 2 of the 5 tumor sites engaged in this research.
NIH NCI Muller, CY (PMC Director), P30 (PI: Willman) 9/1/10-8/30/15
University of New Mexico Cancer Center Support Grant - This competitive renewal provides NCI support for administration, programs, shared resources, clinical trials support, and developmental funds for the University of New Mexico NCI-Designated Cancer Center.
Pfizer B1271004 Muller, CY (PI) 11/18/11-10/31/16
Randomized Phase 2 Non-Comparative Study of the Efficacy of PF-04691502 and PF-05212384 in Patients with Recurrent Endometrial Cancer
Morphotek Muller, CY (PI) 1/14/11-1/14/15
Morphotek MORAb-003-004: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the
Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-Sensitive Ovarian Cancer in First Relapse
Abbott M10-757 Muller, CY (PI) 3/8/10-2/28/15
A Phase 2 Randomized Clinical Trial of ABT-888 in Combination with Temozolomide vs. Pegylated Liposomal Doxorubicin Alone in Subjects with Recurrent High Grade Serous Ovarian Cancer
PharmaMar PM104-B-001-09 Muller, CY (CO-PI) 5/18/09-5/18/14
Phase II Clinical and Pharmacokinetic Trial of PM00104 (Zalypsis®) in Patients with Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated with One Line of Systemic Chemotherapy
CLOSED/COMPLETE
GAP Funding Muller, CY (Co-Investigator) (PI Wandinger-Ness, Co-I Hudson, L) 12/1/11- 11/30/12
UNM Science and Technology Corporation (UNM STC)
Small GTPases as novel targets in ovarian cancer treatment
The goal of this project is to conduct a pilot clinical trial to test the activity of racemic [R,S]-ketorolac within the peritoneal compartment.
ACSIRG, IRG-92-024 Muller, CY (Co-Investigator), (PI: Rutledge) 8/09-8/10
A pilot study to evaluate pelvic floor muscle training vs. no treatment for urinary incontinence among gynecologic cancer survivors
CRC 0503 Muller, CY (PI) 11/30/2006 –5/6/10
Phase I/II Lapatinib plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian Cancer Patients
This is a Phase I/II clinical trial of oral lapatinib plus weekly low dose chemotherapy in patients with measurable relapsed ovarian cancer. (Closed to accrual – patient’s still in follow-up).
GlaxoSmithKline VEG105281 Muller, CY (PI) 10/19/07-10/1/08
A Phase II, Open-Label, Randomized Multicenter Trial of Pazopanib (GW786034)in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB/Metastatic or Recurrent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
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PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Continuation Format Page