PaulaM.FracassoMDPhD, FACP

Oncology • Richmond, VA

Breast Cancer, Gynecologic Cancer, Hematologic Oncology

Professor of Medicine and Gynecologic Oncology, Virginia Commonwealth University School of Medicine

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Office
VCU Massey Cancer Center
401 College Street
Richmond, VA 23298
Phone+1 804-628-0660
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Summary

Board-certified medical oncologist, academic leader, and pharmaceutical executive with significant experience building cancer centers in academic medical centers and developing oncology drugs in biopharmaceutical companies. Expertise in preclinical, translational and clinical development of cellular and immuno-oncology therapies including clinical trial design, regulatory strategies, translational medicine, biomarkers/companion diagnostics, pharmacology, and medical oncology for the delivery of cutting-edge patient care.

Education & Training

Tufts Medical CenterFellowship, Hematology and Medical Oncology, 1989 - 1991
Beth Israel Deaconess Medical CenterResidency, Internal Medicine, 1984 - 1987
Yale School of MedicineClass of 1984, MD, PhD, Alpha Omega Alpha

Certifications & Licensure

MO State Medical License 1991 - 2025
VA State Medical License 2007 - 2024
PA State Medical License 2015 - 2024
American Board of Internal Medicine Internal Medicine
American Board of Internal Medicine Medical Oncology

Awards, Honors, & Recognition

Alpha Omega Alpha
Phi Beta Kappa
CMS Meaningful Use Stage 1 Certification EpicCare Ambulatory EMR, Epic Systems Corporation, 2013

Clinical Trials

Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers Start of enrollment: 1998 Mar 01
Completed
Phase 1
Oxaliplatin in Treating Patients With Recurrent or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Has Not Responded to Platinum- Based Chemotherapy Start of enrollment: 2000 Feb 01
Completed
Phase 2
Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer Start of enrollment: 2000 Feb 01
Completed
Phase 2
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer Start of enrollment: 2000 May 01
Completed
Phase 2
7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) Start of enrollment: 2001 Dec 01
Completed
Phase 1
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer Start of enrollment: 2003 Sep 01
Completed
Phase 1
Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer Start of enrollment: 1999 Nov 01
Completed
Phase 2
Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery Start of enrollment: 2011 Sep 01
Terminated
Phase 1
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Publications & Presentations

PubMed

Durable control of metastases in an HLA-A2+ patient with refractory melanoma after low-dose radiotherapy in combination with MAGE-A4 T cell therapy: a case report.
Kewen He, David S Hong, Danxia Ke, Partow Kebriaei, Tianjiao Wang, Hassan Danesi, Genevieve Bertolet, Carola Leuschner, Nahum Puebla-Osorio, Tiffany A Voss, Quan Lin, ...> ;Melanoma Research. 2023 Aug 1
A Phase I Trial of the ABCB1 Inhibitor, Oral Valspodar, in Combination With Paclitaxel in Patients With Advanced Solid Tumors.
Paula M Fracasso, George A Fisher Jr, Sherry A Goodner, Jan H Beumer, Merrill J Egorin, Carole L Fears, Jonathan D Wildi, Gary J Jones, Tillman E Pearce, Branimir I Sikic> ;American Journal of Clinical Oncology. 2023 Aug 1
24 citations
Autologous T cell therapy for MAGE-A4solid cancers in HLA-A*02patients: a phase 1 trial.
David S Hong, Brian A Van Tine, Swethajit Biswas, Cheryl McAlpine, Melissa L Johnson, Anthony J Olszanski, Jeffrey M Clarke, Dejka Araujo, George R Blumenschein Jr, Pa...> ;Nature Medicine. 2023 Jan 1
A Phase I Study of Apolizumab, an Anti-HLA-DR ß-chain Monoclonal Antibody, in Patients With Solid Tumor Malignancies.
Paula M Fracasso, Sherry A Goodner, Jonathan D Wildi, Michael J Naughton, Gerald P Linette, Ramaswamy Govindan, Benjamin R Tan, Kristie A Blum, Gary J Jones, Tillman E...> ;American Journal of Clinical Oncology. 2022 Jul 1
An Exploratory Study of Neoadjuvant Cetuximab Followed by Cetuximab and Chemoradiotherapy in Women With Newly Diagnosed Locally Advanced Cervical Cancer.
Paula M Fracasso, Linda R Duska, Premal H Thaker, Feng Gao, Imran Zoberi, Farrokh Dehdashti, Livnat Uliel, Christine O Menias, Patrice K Rehm, Sherry A Goodner, Alliso...> ;American Journal of Clinical Oncology. 2022 Jul 1
17 citations
Phase I clinical trial evaluating the safety and efficacy of ADP-A2M10 SPEAR T cells in patients with MAGE-A10advanced non-small cell lung cancer.
George R Blumenschein, Siddhartha Devarakonda, Melissa Johnson, Victor Moreno, Justin Gainor, Martin J Edelman, John V Heymach, Ramaswamy Govindan, Carlos Bachier, Ber...> ;Journal for Immunotherapy of Cancer. 2022 Jan 1
7 citations
Phase 1 Clinical Trial Evaluating the Safety and Anti-Tumor Activity of ADP-A2M10 SPEAR T-Cells in Patients With MAGE-A10+ Head and Neck, Melanoma, or Urothelial Tumors.
David S Hong, Marcus O Butler, Russell K Pachynski, Ryan Sullivan, Partow Kebriaei, Sarah Boross-Harmer, Armin Ghobadi, Matthew J Frigault, Ecaterina E Dumbrava, Amy S...> ;Frontiers in Oncology. 2022 Jan 1
4 citations
Phase I Study of Docetaxel and Temsirolimus in Refractory Solid Tumors.
Manik Amin, Feng Gao, Gretel Terrero, Joel Picus, Andrea Wang-Gillam, Rama Suresh, Cynthia Ma, Benjamin R. Tan, Maria Q. Baggstrom, Michael J. Naughton, Lauren Trull, ...> ;American Journal of Clinical Oncology. 2021 Sep 1
4 citations
Post hoc analyses of GOG 9923: Does BRCA status affect toxicities?: An NRG oncology study.
J. Gillen, Austin Miller, Katherine M. Bell-McGuinn, Russell J. Schilder, Joan L. Walker, Cara Mathews, Linda R. Duska, Saketh R. Guntupalli, Roisin E. O'Cearbhaill, J...> ;Gynecologic Oncology. 2021 May 1
28 citations
Phase II study of axalimogene filolisbac (ADXS-HPV) for platinum-refractory cervical carcinoma: An NRG oncology/gynecologic oncology group study
Warner K. Huh, William E. Brady, Paula M. Fracasso, Don S. Dizon, Matthew A. Powell, Bradley J. Monk, Charles A. Leath, Lisa M. Landrum, Edward J. Tanner, Erin K. Cran...> ;Gynecologic Oncology. 2020 Sep 1
9 citations
A phase I study of intravenous or intraperitoneal platinum based chemotherapy in combination with veliparib and bevacizumab in newly diagnosed ovarian, primary periton...
Kathleen N. Moore, Austin Miller, Katherine M. Bell-McGuinn, Russell J. Schilder, Joan L. Walker, Roisin E. O'Cearbhaill, Saketh R. Guntupalli, Deborah K. Armstrong, A...> ;Gynecologic Oncology. 2020 Jan 1
55 citations
Sequential Ipilimumab After Chemoradiotherapy in Curative-Intent Treatment of Patients With Node-Positive Cervical Cancer.
Jyoti Mayadev, Danielle Enserro, Yvonne G. Lin, Diane M. Da Silva, Heather A. Lankes, Carol Aghajanian, Sharad A. Ghamande, Kathleen N. Moore, Vanessa A Kennedy, Paula...> ;JAMA Oncology. 2020 Jan 1
24 citations
Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study.
Shannon N. Westin, Michael W. Sill, Robert L. Coleman, Steven E. Waggoner, Kathleen N. Moore, Cara Mathews, Lainie P. Martin, Susan C. Modesitt, Sanghoon Lee, Zhenlin ...> ;Gynecologic Oncology. 2019 Dec 1
27 citations
An Integrative Approach to Inform Optimal Administration of OX40 Agonist Antibodies in Patients with Advanced Solid Tumors.
Rui Wang, Chan Gao, Megan Raymond, Gennaro Dito, Dominic Kabbabe, Xiao Shao, Ed Hilt, Yongliang Sun, Irene Pak, Martin Gutierrez, Ignacio Melero, Anna Spreafico, Richa...> ;Clinical Cancer Research. 2019 Nov 15
6 citations
A window-of-opportunity clinical trial of dasatinib in women with newly diagnosed endometrial cancer.
Linda R. Duska, Gina R. Petroni, Heather Lothamer, William Faust, Jan H. Beumer, Susan M. Christner, Anne M. Mills, Paula M. Fracasso, Sarah J. Parsons> ;Cancer Chemotherapy and Pharmacology. 2019 Mar 1
11 citations
The Fast Real-time Assessment of Combination Therapies in Immuno-ONcology (FRACTION) program: innovative, high-throughput clinical screening of immunotherapies.
Katy L. Simonsen, Paula M. Fracasso, Steven H. Bernstein, Megan Wind-Rotolo, Manish Gupta, Adriana Comprelli, Timothy P. Reilly, Cassidy James> ;European Journal of Cancer. 2018 Nov 1
10 citations
A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cerv...
Cecelia H. Boardman, William E. Brady, Don S. Dizon, Charles A. Kunos, Kathleen N. Moore, Kristine M. Zanotti, Cara Matthews, Jonathan A. Cosin, Carol Aghajanian, Paul...> ;Gynecologic Oncology. 2018 Nov 1
30 citations
A phase I trial of intraperitoneal GEN-1, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer, administered with pegylated liposomal doxorubicin in patien...
Premal H. Thaker, William E. Brady, Kunle Odunsi, William H. Bradley, Kathleen N. Moore, Carolyn Y. Muller, Khursheed Anwer, Russell J. Schilder, Ronald D. Alvarez, Pa...> ;Gynecologic Oncology. 2017 Nov 1
27 citations
Integrative Development of a TLR8 Agonist for Ovarian Cancer Chemoimmunotherapy.
Bradley J. Monk, Andrea Facciabene, William E. Brady, Carol Aghajanian, Paula M. Fracasso, Joan L. Walker, Heather A. Lankes, Kristi Manjarrez, Gwenn Danet-Desnoyers, ...> ;Clinical Cancer Research. 2017 Apr 15
44 citations
A Phase II study of Dovitinib in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
Patrick M. Dillon, Gina R. Petroni, Bethany J. Horton, Christopher A. Moskaluk, Paula M. Fracasso, Michael G. Douvas, Nikole Varhegyi, Snjezana Zaja-Milatovic, Christo...> ;Clinical Cancer Research. 2017 Aug 1
15 citations
A phase I pharmacokinetic study of intraperitoneal bortezomib and carboplatin in patients with persistent or recurrent ovarian cancer: An NRG Oncology/Gynecologic Onco...
Danielle A. Jandial, William E. Brady, Stephen B. Howell, Heather A. Lankes, Russell J. Schilder, Jan H. Beumer, Susan M. Christner, Sandra Strychor, Matthew A. Powell...> ;Gynecologic Oncology. 2017 May 1
48 citations
A phase I trial of paclitaxel, cisplatin, and veliparib in the treatment of persistent or recurrent carcinoma of the cervix: an NRG Oncology Study (NCT#01281852)
Premal H. Thaker, Ritu Salani, W. E. Brady, Heather A. Lankes, David E. Cohn, David G. Mutch, Robert S. Mannel, Katherine M. Bell-McGuinn, P. A. Di Silvestro, Danijela...> ;Annals of Oncology. 2017 Mar 1
4 citations
A phase I study of IV doxorubicin plus intraperitoneal (IP) paclitaxel and IV or IP cisplatin in endometrial cancer patients at high risk for peritoneal failure (GOG 9...
D. Scott McMeekin, Michael W. Sill, Joan L. Walker, Kathleen N. Moore, Steven E. Waggoner, Premal H. Thaker, Tina Rizack, James S. Hoffman, Paula M. Fracasso> ;Gynecologic Oncology. 2015 Jul 1
34 citations
A phase I trial of pegylated liposomal doxorubicin (PLD), carboplatin, bevacizumab and veliparib in recurrent, platinum-sensitive ovarian, primary peritoneal, and fall...
Lisa M. Landrum, William E. Brady, Deborah K. Armstrong, Kathleen N. Moore, Paul DiSilvestro, David M. O'Malley, Meaghan Tenney, Peter G. Rose, Paula M. Fracasso> ;Gynecologic Oncology. 2015 Apr 1
3 citations
A phase I study of pegylated liposomal doxorubicin and temsirolimus in patients with refractory solid malignancies.
Andrea Wang-Gillam, Nilay Thakkar, A. Craig Lockhart, Kerry J. Williams, Maria Q. Baggstrom, Michael Naughton, Rama Suresh, Cynthia X. Ma, Benjamin R. Tan, Wooin Lee, ...> ;Cancer Chemotherapy and Pharmacology. 2014 Jun 11
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Authored Content

The Fast Real-Time Assessment of Combination Therapies in Immuno-ONcology (FRACTION) Program: Innovative, High-Throughput Clinical Screening of ImmunotherapiesOctober 2018

Press Mentions

Paula Fracasso Joins VCU Massey Cancer Center to Lead the Cancer Service LineSeptember 14th, 2022
VCU Massey Cancer Center Names Dr. Paula Fracasso New Deputy DirectorSeptember 7th, 2022
Global Cancer Rates in People 50 and Younger on the Rise, Study FindsSeptember 7th, 2022
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Grant Support

An Exploratory Study Of UCN-01 And Irinotecan In Advanced Triple Negative BreastNational Cancer Institute2007–2008
Overcoming Barriers To Early Phase Clinical TrialsNational Cancer Institute2003–2004
Oral SDZ PSC 833 And Intravenous Paclitaxel In Advanced CancerNational Center For Research Resources1998–1999
Taxol And SDZ PSC 833 In Patients With Refractory MalignanciesNational Center For Research Resources1997–1999
Oral SDZ PSC 833 And Intravenous Paclitaxel In Advance CancerNational Center For Research Resources1996
Comparison Of CDNA Transcripts Of MDR Genes In The MouseNational Cancer Institute1990–1991
Comparison Of CDNA Transcripts Of MDR Genes In The MouseNational Cancer Institute1988