The Hoosier Cancer Research Network multi-center BRE12-158 study on triple-negative breast cancer (TNBC), led by Indiana University Melvin and Bren Simon Comprehensive Cancer Center, was recently presented as a Spotlight Poster Discussion during the 2020 San Antonio Breast Cancer Symposium virtual meeting.

The correlative analysis from the study, “A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer,” found patients with circulating tumor DNA (ctDNA) after neoadjuvant chemotherapy (NAC), who had a presence of TP53 mutations, had a greater chance of rapid disease recurrence.

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Hoosier Cancer Research Network recently welcomed Vivian Cintron, PhD, MBA, as its first chief operating officer. In her new role, she will work closely with HCRN’s executive director, Cyndi Burkhardt, and the management team to support company operations and strengthen relationships with investigators, key opinion leaders, and industry collaborators.

Dr. Cintron is a molecular biologist and geneticist with more than 25 years of executive global experience in medical, scientific affairs, clinical trials, and strategic business development, working with Roche Diagnostics, DiaSorin, and Cepheid. She is a strategic visionary with a strong business acumen and comprehensive knowledge in the area of oncology therapeutics. A former captain in the US Army Reserve, Dr. Cintron holds an executive leadership certification from Cornell University, completed postdoctoral trainings at the National Institutes of Health and Eli Lilly and Co., and obtained an MBA and Master of Science in Strategic Management from Indiana University Kelly Business School. Read More

Hoosier Cancer Research Network, a nonprofit cancer research organization based in Indianapolis, recently welcomed Indiana University School of Medicine research nurse Alesha Arnold, RN, as a member of its Board of Directors.

Arnold joined the IU School of Medicine in 2008 and supports the Clinical Trials Office at the IU Melvin and Bren Simon Comprehensive Cancer Center. Prior to that she worked at IU Health Methodist Hospital for the cardiovascular medicine unit. She also worked in pediatrics and for a local pharmaceutical company, where she worked in the product safety division and eventually in research. Additionally, Arnold is a member of the Society of Clinical Research Associates (SOCRA).

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Since Christopher A. Fausel, PharmD, MHA, BCOP, was appointed as Chairman of the Board of Directors for Hoosier Cancer Research Network in July 2013, he has guided HCRN through tremendous growth, two moves, and now – a pandemic. He has also helped HCRN raise more than $23,000 through HCRN’s Reps for Research challenge.

From 2014 to 2019, HCRN grew from managing around 15 studies at 130 clinical research sites to more than 80 studies at 450 clinical research sites. Currently, more than 55 sponsor-investigators lead studies within the HCRN network — and other member providers can develop study concepts within HCRN’s Clinical Trial Working Groups in specific cancer areas.

Fausel, oncology precision genomics pharmacist at Indiana University Melvin and Bren Simon Comprehensive Cancer Center, was encouraged to get involved in HCRN in 1998, at the invitation of HCRN co-founder, Patrick J. Loehrer, Sr., MD, distinguished professor at the Indiana University School of Medicine and director of the IU Melvin and Bren Simon Comprehensive Cancer Center. Read More

Two Indiana University School of Medicine hematology-oncology fellows are digging deep into timely cancer research questions, with research support provided by the George and Sarah Jane Fisher Fund.

Melissa Yan, MD, and Nikhil Shukla, MD, are investigating biomarkers that may one day provide more personalized solutions in treating lung cancer. Each award recipient received $6,000 to support their oncology research. William B. Fisher, MD, co-founder of Hoosier Cancer Research Network (HCRN) established the George and Sarah Jane Fisher Fund in the late 1990s in memory of his mother, Sarah Jane, and brother, George, both of whom died of cancer. Read More

This month, Hoosier Cancer Research Network features our member institution, the University of Michigan Rogel Cancer Center, and Ulka Nitin Vaishampayan, MBBS, FAB, director of the phase I program at Rogel Cancer Center and a professor of internal medicine at the University of Michigan Medical School. Dr. Vaishampayan is leading an HCRN multi-institution study that will investigate pembrolizumab and lenvatinib in advanced/metastatic neuroendocrine prostate cancer. She is a site principal investigator on HCRN bladder cancer studies GU14-182 and GU15-262, and a co-investigator on the Big Ten Cancer Research Consortium kidney cancer study BTCRC-GU16-043. She is a member of the HCRN Genitourinary Clinical Trial Working Group. Read More

This month, Hoosier Cancer Research Network features our member, the Huntsman Cancer Institute at the University of Utah and Benjamin Maughan, MD, PharmD, assistant professor in the Division of Medical Oncology at Huntsman Cancer Institute, who specializes in genitourinary cancers.

Dr. Maughan is a site principal investigator for the HCRN bladder cancer studies GU16-257, GU16-287, and GU17-294, and a member of the HCRN Genitourinary Clinical Trial Working Group.

Research Interests and Expertise

Dr. Maughan’s research focus is on studying innate and acquired resistance mechanisms to therapy in genitourinary malignancies. In metastatic prostate cancer, he has studied how resistance pathways may play a role in expression of truncated androgen receptors (e.g., AR-V7 expression) and loss of tumor suppressors such as PTEN and Rb. More recently, Dr. Maughan has studied the resistance mechanisms toward immunotherapy in metastatic bladder, kidney, and prostate cancers in the context of novel immune therapy combinations for each of these cancers. For instance, one of his investigator-initiated clinical trials involves a combination of cancer vaccines (PSA and brachyury antigen directed) in combination with PD-L1 inhibition. Read More

Hoosier Cancer Research Network investigators recently presented an E-Poster on the HCRN study GU18-343 during the ESMO 2020 Virtual Congress.

The multi-center clinical trial, “A Phase 2 Study of Cabozantinib in Combination with Atezolizumab as NeoAdjuvant Treatment for Muscle-Invasive BladdEr Cancer (ABATE),” is led by Deepak Kilari, MD, a medical oncologist and researcher at Froedtert & the Medical College of Wisconsin. The study is now enrolling subjects at the Medical College of Wisconsin. Additional participating institutions will include Hackensack University, the University of North Carolina at Chapel Hill, the University of Rochester, and Vanderbilt University.

The study is a single-arm, open-label clinical trial that is assessing the safety and efficacy of combining cabozantinib and atezolizumab as a neoadjuvant therapy in adult patients with muscle-invasive bladder cancer, with a focus on cisplatin-ineligible patients. Read More

This month, Hoosier Cancer Research Network features our member, the University of Wisconsin Carbone Cancer Center, and Christos Kyriakopoulos, MD, associate professor of medicine at the University of Wisconsin School of Medicine and Public Health, and a medical oncologist and researcher at UW Carbone Cancer Center.

Research Interests and Expertise

Dr. Kyriakopoulos is an institutional principal investigator for the HCRN study GU16-257, “Neoadjuvant gemcitabine, cisplatin, plus nivolumab in patients with muscle-invasive bladder cancer with selective bladder sparing.” His research interests include clinical trials in prostate cancer, bladder cancer, and kidney cancer. He is particularly interested in imaging and immunotherapy studies in prostate cancer. He is also the study chair of the national trial EA8153, a study led by the ECOG-ACRIN Cancer Research Group in collaboration with the National Cancer Institute (NCI), that examines the role of chemo-hormonal therapy in patients with metastatic castration-resistant prostate cancer who have already received docetaxel. Read More

The Hoosier Cancer Research Network study, LUN14-179, “A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab (MK-3475) for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): HCRN LUN14-179,” affirms the effectiveness of consolidation immunotherapy after chemoradiation in adults with unresectable stage IIIA or IIIB non-small cell lung cancer. The study demonstrates that the addition of pembrolizumab in Stage III NSCLC may be associated with prolonged time to metastatic disease or death (TMDD), progression-free survival (PFS) and overall survival (OS), after treatment with chemoradiation. The findings were recently published in the Clinical Lung Cancer journal and American Cancer Society’s Cancer journal. The median TMDD was 30.7 months, the median PFS was 18.7 months, and the median OS was 35.8 months. Read More

This month, Hoosier Cancer Research Network features our member Fred Hutchinson Cancer Research Center and William P. Harris, MD, associate professor of medicine for the University of Washington School of Medicine and a medical oncologist at Fred Hutch.

Research Interests and Expertise

Dr. Harris is a GI medical oncologist with a main research focus on hepatobiliary oncology. Specific areas of interest include interventional trials targeting therapy for patients with hepatocellular carcinoma and biliary tract cancers, and retrospective and prospective analyses assessing translational biomarkers and imaging features, which might predict response to systemic therapeutic interventions and combinations of local therapeutics and systemic therapy in treating liver tumors. Additional areas of involvement include medical education in medical oncology for pre-clinical medical school students, global health teaching, collaboration with the Uganda Cancer Institute, and involvement with patient advocacy foundations that optimize use of resources to facilitate research and patient care for patients with GI malignancies. Read More

This month, Hoosier Cancer Research Network features our member Penn Medicine Abramson Cancer Center and Naomi Haas, MD, Director of Kidney and Prostate Cancer Clinical Research at Penn Medicine and Associate Professor of Medicine at the Hospital of University of Pennsylvania. Dr. Haas is an international expert in the conduct and design of adjuvant clinical trials for kidney cancer and a national expert in prostate and kidney cancer therapeutics. Dr. Haas is an institutional principal investigator for the HCRN study GU16-260, “Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma,” and participated in GU16-257, “Neoadjuvant gemcitabine, cisplatin, plus nivolumab in patients with muscle-invasive bladder cancer with selective bladder sparing.”

Research Interests and Expertise

Dr. Haas’ research interests include early phase cancer clinical trials in kidney cancer, prostate cancer, and studying emerging treatment plans including those that use CAR T-Cell therapy, immune checkpoint inhibition, angiogenesis, and epigenetics. She also gained experience in retrotransposon, a type of genetic component that copies and pastes itself in different genomic locations by converting RNA back to DNA, through her early work in a basic science lab at Fox Chase Cancer Center. Read More

This month, Hoosier Cancer Research Network features our member Georgetown Lombardi Comprehensive Cancer Center and Michael B. Atkins, MD, deputy director of the cancer center, William M. Scholl Professor, and vice chair of the Department of Oncology. Dr. Atkins is an international leader in translational and clinical research, with more than 30 years of experience working on melanoma, kidney cancer, and cancer immunotherapy research. He is a member of the HCRN Genitourinary Clinical Trial Working Group and is sponsor-investigator of the HCRN GU16-260 clinical trial. He also serves as chair of the Medical Advisory Panel for the Melanoma Research Alliance and co-chair of the Scientific Advisory Committee and board member for the Melanoma Research Foundation.

Prior to working at Georgetown, Dr. Atkins worked as a professor at Harvard Medical School and served in multiple leadership roles, including deputy chief of the Division of Hematology/Oncology, director of the Cancer Clinical Trials Office, leader of the Biologic Therapy and Cutaneous Oncology Programs at Beth Israel Deaconess Medical Center, co-principal investigator of the Harvard Skin Cancer SPORE, leader of the Dana Farber Harvard Cancer Center Kidney Cancer Program, and director of the DF/HCC Kidney Cancer SPORE.

Research Interests and Expertise

Dr. Atkins’ research interests include immunotherapy, anti-angiogenic therapy, molecular targeted therapy, and predictive biomarker development, particularly in kidney cancer and melanoma. He has published more than 450 research and review articles, four books and has lectured extensively in these areas. He is associate editor of the Journal of Immunotherapy and serves on the editorial board of the Journal for Immunotherapy of Cancer. Read More

Erica Stringer-Reasor, MD, assistant professor of medicine in the Division of Hematology & Oncology at the University of Alabama at Birmingham (UAB), has been appointed as a co-chair of the Hoosier Cancer Research Network (HCRN) Breast Cancer Clinical Trial Working Group.

Dr. Stringer-Reasor joins fellow co-chair Carey K. Anders, MD, a professor of medicine at Duke University School of Medicine and a medical oncologist and researcher at Duke Cancer Institute (DCI). She succeeds Filipa Lynce, MD, a medical oncologist at Dana-Farber Cancer Institute, who recently completed her term as co-chair. HCRN co-chairs serve two-year terms and may serve additional terms with the support of their colleagues.

Clinical Trial Working Groups (CTWGs) provide a forum where researchers from member institutions collaborate to discuss and develop study concepts, identify potential co-investigators and sites to participate in studies, and review the progress of ongoing clinical trials. CTWGs also provide junior investigators an opportunity to receive scientific feedback and mentorship from their senior peers. The Breast Cancer CTWG meets by teleconference every other month, and (when face-to-face meetings are possible) in-person during the American Society of Clinical Oncology (ASCO) and San Antonio Breast Cancer Symposium annual meetings. Read More

A phase II study for adults with extensive-stage small cell lung cancer is testing the hypomethylating agent guadecitabine combined with the platinum-based chemotherapy drug carboplatin. The study is open to accrual at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, Ind.; IU Health Ball Memorial Cancer Center in Muncie, Ind.; and the University of Virginia Cancer Center in Charlottesville, Va.

More than 234,000 new cases of lung and bronchus cancer were estimated for 2018, 10 to 15 percent of which are small cell lung cancer. Small cell lung cancer is often treated with chemotherapy, which could be a platinum-based drug or another form of chemotherapy. However, eventually patients’ cancers stop responding to these drugs.

The HCRN study, LUN17-302, “A Phase II Study Evaluating Efficacy and Safety of Hypomethylating Agent Guadecitabine in Combination with Carboplatin in Extensive Stage Small Cell Lung Cancer,” will help determine whether the combination of guadecitabine with carboplatin is better, the same, or worse than the standard treatment and will evaluate the good and bad effects of this combined therapy. Read More

Investigators participating in Hoosier Cancer Research Network’s Thoracic Clinical Trial Working Group have named three of their colleagues to serve as co-chairs of the group. The new co-chairs are (pictured from left) Greg Durm, MD, assistant professor of clinical medicine at Indiana University School of Medicine and a researcher at the IU Melvin and Bren Simon Comprehensive Cancer Center; Mary Jo Fidler, MD, associate professor, Department of Internal Medicine at Rush Medical College, Rush University; and Ryan Gentzler, MD, associate professor of medicine: hematology and oncology at the University of Virginia School of Medicine. They succeed former co-chairs Karen L. Reckamp, MD, MS, director of the Division of Medical Oncology at Cedars-Sinai Cancer, and Rachel E. Sanborn, MD, medical oncologist at Providence Cancer Institute. HCRN co-chairs serve two-year terms with the potential to serve additional terms with the support of their colleagues. Read More

A Hoosier Cancer Research Network study is testing a treatment combination for patients with gastric or esophageal cancer. The phase II study, HCRN GI17-319, focuses on adult patients whose cancer cannot be removed by surgery or has metastasized, and possess an amplification of the gene known as human epidermal growth factor receptor 2 (HER2).

The study, “A single arm, multi-center Phase 2 trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas,” explores whether adding avelumab, a PD-L1-targeting drug to chemotherapy and trastuzumab, a HER2-targeted therapy, will control a patient’s cancer for a longer period compared to the current standard treatment. It will also test the safety and tolerability of this combined therapy. Read More

Researchers at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center are leading a multi-site phase II study through the Hoosier Cancer Research Network for previously treated metastatic esophageal cancer patients with specific genetic mutations. The study is now open to accrual at the IU Simon Cancer Center, Moffitt Cancer Center, and Roswell Park Cancer Institute.

The study, HCRN ESO17-325, “A Phase II Study Evaluating Safety and Efficacy of Niraparib in Patients with Previously Treated Homologous Recombination Defective or Loss of Heterozygosity high Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma,” will test the effectiveness of using the PARP inhibitor, niraparib, versus the current standard of care, in treating patients with one of three genetic mutations, including homologous recombination (HR) mutation in tumor tissue; high rate of loss of heterozygosity (LOH) in tumor tissue; or a germline mutation in the blood. The study uses precision medicine by applying patients’ genetic information to guide treatment decisions. Read More

This month, Hoosier Cancer Research Network (HCRN) features our member City of Hope and Joseph Chao, MD, a medical oncologist and researcher at the cancer center. Dr. Chao is a member of the HCRN Gastrointestinal Clinical Trial Working Group and has participated as an investigator on the HCRN GI16-288 and GI17-319 studies.

Research Interests and Expertise

I am a GI medical oncologist with a clinical focus on caring for patients with gastroesophageal cancers. My research interests involve clinical trials exploring novel therapeutics that are continually needed for this disease, particularly in advanced stages. Realizing that improving precision medicine and immunotherapy approaches requires in-depth knowledge of oncogenic mechanisms and tumor biology, I have extended my research efforts into translational analyses and biomarker development. Recent interests include work exploring more in-depth gastroesophageal cancer intrapatient intratumoral heterogeneity and its impact on the tumor immune microenvironment. Read More

Results from a multi-site clinical trial for patients with triple-negative breast cancer (TNBC) show that genomic testing for circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) after neoadjuvant chemotherapy can be used to detect residual disease and identify which patients could be at high risk of relapse. The results were recently published in JAMA Oncology.

The preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive post-neoadjuvant genomically directed therapy vs. treatment of physician choice. The study was led by the Indiana University School of Medicine and managed by Hoosier Cancer Research Network. Read More