A native Hoosier, William Ian Towler is the Regulatory Manager for the Indiana University Melvin and Bren Simon Cancer Center. “My job is to make sure we function as smoothly as possible,” Towler says.

[Photo: Ian Towler (left) and HCRN co-founder and William B. Fisher, MD.]

The breadth of Towler’s impact is as wide as his responsibility. “My group is responsible for all the IRB submissions, all the ClinicalTrials.gov submissions, all the FDA IND submissions; so anything that might have a regulatory body, we are responsible for making sure we get them in on time and appropriately.”

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Hoosier Cancer Research Network is pleased to announce the opening of a cancer clinical trial for subjects with metastatic castrate-resistant prostate cancer at select sites throughout the United States.

The study, known as GU14-202, is designed to assess the safety and toxicity of an investigational drug called niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, given in combination with an anti-androgen drug called enzalutamide. The FDA approved enzalutamide for the treatment of castrate-resistant prostate cancer in 2012, but it has not yet approved niraparib.

PARP is a group of proteins that are involved with DNA repair. According to study co-investigator John Paul Flores, MD, of Tufts Medical Center, castrate-resistant prostate cancer often involves defects in DNA repair. Read More

A new Hoosier Cancer Research Network study is exploring the effects of pembrolizumab in treating metastatic urothelial cancer. The study, known as GU14-182, will compare maintenance pembrolizumab to a placebo in subjects after first-line chemotherapy for metastatic urothelial cancer (e.g., cancer of the bladder, urethra, ureter, or renal pelvis).

The study is currently open to accrual at the Tisch Cancer Institute at Mount Sinai.

The standard approach to treating metastatic urothelial cancer is chemotherapy administered for about 4-6 cycles. If the disease has stabilized or responded, treatment is usually stopped and patients are monitored until their cancer starts to grow again. This is the standard approach because continuing additional standard chemotherapy usually leads to an increase in side effects without necessarily improving the results achieved with chemotherapy. GU14-182 will test whether or not this “stop and wait” approach can be improved by administering pembrolizumab following chemotherapy, according to the study’s sponsor investigator, Matthew Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai. Read More

Hoosier Cancer Research Network chairman Christopher A. Fausel, PharmD, is once again combining his passion for investigator-initiated research with his annual participation in the Arnold Sports Festival Pump & Run 5K in Columbus, Ohio.

Fausel has participated in the annual strength and endurance event for several years, and is inviting pledges in support of Hoosier Cancer Research Network (HCRN) for every bench press “rep” he completes (maximum of 30) during the event on Sunday, March 6. Read More

In the dark world of cancer, there are those who shine like bright beacons of hope and guidance for many. Hoosier Cancer Research Network (HCRN) annually recognizes the role that spirited patient advocates and champions of oncological progress fill through the Terry Hoeppner Patient Advocacy Award, named in memory of beloved Indiana University football coach Terry Hoeppner, who died from brain cancer in 2007. The award honors individuals who exhibit Coach Hep’s spirit and determination to champion their cause.

HCRN recently honored Diane Zipursky Quale with the award in recognition of her long-standing support for cancer research and patient advocacy. President and co-founder of Bladder Cancer Advocacy Network (BCAN), Quale has been a champion of the bladder cancer community for more than 10 years.  Her story of uncommon determination reflects the characteristic spirit of her late husband, attorney John Quale, and of Coach Hep, two men who “never quit.” Read More

In an oral abstract session at the 2016 Genitourinary Cancers Symposium, Matthew Galsky, MD, reported on the HCRN GU10-148 study, a phase II trial of gemcitabine and cisplatin plus ipilimumab as first-line treatment for patients with metastatic urothelial carcinoma. Dr. Galsky (pictured), of the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, is sponsor-investigator of the multi-center trial. Read More

Around six years ago, Stephen Glick was a businessman, a manager of supply chains in manufacturing. Today, he is a regulatory affairs specialist at IU Health Goshen Center for Cancer Care. His personal journey from one professional world to the next is the story of compassion forging sustained professional commitment that contributes to progress in oncological care.

[Photo: Stephen Glick (right) and HCRN’s Senior Clinical Regulatory Manager, Lucienne Augustin.]

“There came a time when I felt the need to do something completely different,” Glick recalls. “I felt like I really wanted to do something in healthcare instead of the business world. Healthcare had some new meaning for me.”

Glick found that “new meaning” through his own intimate encounters with clinical oncology. “I was influenced by the fact that my wife is a breast cancer survivor.” He remembers “going to the infusion room and talking to the other cancer patients that were there and seeing the real-life struggles.” Read More

In a new journal article published online ahead of print in Supportive Care in Cancer, Hoosier Cancer Research Network investigators reported on results of QL12-153, a phase II study of fosaprepitant + 5HT3 receptor agonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy. The multi-center study was led by sponsor investigator Lawrence H. Einhorn (pictured), of the Indiana University School of Medicine. Read More

Hoosier Cancer Research Network recently opened a cancer clinical trial for subjects with advanced colorectal cancer. The study, known as GI14-186, involves the study drug called pembrolizumab, given in combination with mFOLFOX6, a standard chemotherapy regimen for advanced colorectal cancer. The study is currently open to accrual at the Indiana University Melvin and Bren Simon Cancer Center, The Ohio State University, and Winship Cancer Institute of Emory University.

Cancer cells often create proteins called PD-1 that act as signals to turn off part of the immune system that recognizes cancer as foreign. Pembrolizumab blocks this signal and allows the immune system to recognize and attack these cancer cells.

The use of pembrolizumab in combination with mFOLFOX6 is investigational. This means that the FDA has not approved this combination of drugs for this type of cancer. This study will allow researchers to know whether adding pembrolizumab to the usual chemotherapy drugs makes the treatment work better, the same, or worse than the usual approach.

Participants in this study must have advanced colorectal cancer, and have not had prior systemic therapy for advanced or metastatic disease. Additional criteria must be met to be eligible for this study. Read More

Hoosier Cancer Research Network recently launched a Symptom Management Clinical Trial Working Group. The group grew out of a desire to see improvements in quality of life for patients, from diagnosis through survivorship.

Formation of the group was sparked by Julie Otte, PhD, RN, OCN from the Indiana University School of Nursing and her commitment to enhancing the patient experience. “It’s one thing to do this great research, but it has to be something that eventually makes it to the patient,” said Otte, co-chair of the group. Read More

In 2009, Osama Rahma, MD, was settling in to the National Institutes of Health as part of a team that focused on the development of cancer vaccines and the emerging field of cancer immunotherapy. It was a time when the interaction between the immune system and cancer cells was just starting to become clear.

“We were pretty naïve in thinking that you can just stimulate these immune cells by injecting the vaccine with a specific target in patients and try to stimulate the immune response,” he recalls, “but later on we started learning about what we now call immune checkpoint inhibitors. Those are more powerful drugs that actually target the break in the immune system and unleash the immune system to attack the cancer cells.”

Six years later, Dr. Rahma is now an assistant professor of medicine in the Division of Hematology/Oncology at the University of Virginia School of Medicine, and the promise of immunotherapy has begun to bear fruit. Read More

Former Hoosier Cancer Research Network vice chair Robin T. Zon, MD, FACP, FASCO, has been selected by the American Society of Clinical Oncology (ASCO) Nominating Committee as a candidate for president-elect. Dr. Zon (pictured left) is a vice president and senior partner at Michiana Hematology-Oncology, P.C. She served as HCRN vice chair from 2006 to 2009 and as chief community officer from 2009 to 2010. She has been a member of ASCO since 1997.

In addition, Maha H. A. Hussain, MD, FACP, FASCO, has been nominated for election to the Board of Directors. Dr. Hussain (pictured right) is associate director of clinical research at the University of Michigan Comprehensive Cancer Center, which is a member of Hoosier Cancer Research Network. She was instrumental in the formation of the Big Ten Cancer Research Consortium. Read More

OncoGenex Pharmaceuticals, Inc., recently announced that Borealis-2™, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is managed by Hoosier Cancer Research Network and is being conducted at 27 sites across the United States. The sponsor investigator is Noah Hahn, MD, associate professor of oncology and urology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine.

Patients enrolled in Borealis-2 were randomized to receive either apatorsen plus docetaxel or doecetaxel alone. Patients could continue weekly apatorsen infusions as maintenance treatment until disease progression or unacceptable toxicity if they completed all 10 planned cycles of docetaxel or discontinued from docetaxel due to toxicity. Evaluation of overall survival is the primary study objective. Read More

A new journal article on Hoosier Cancer Research Network’s GU07-122 study will appear in the October 2015 issue of Urologic Oncology. The study was designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of the bladder. Read More

The Bladder Cancer Advocacy Network (BCAN) and Paradigm today announced a partnership for the launch of a large-scale genomically-driven bladder cancer study. Hoosier Cancer Research Network (HCRN) will act as the coordinating center.

This prospective study is the first project of the Bladder Cancer Genomics Consortium (BCGC), a collaborative effort between BCAN and major medical centers. The BCGC’s goal is to develop an enriched understanding of the genomic profile of bladder cancer to facilitate the development of novel therapeutics. Bladder cancer is the fifth most commonly diagnosed cancer in the U.S., with nearly 75,000 new cases and 16,000 deaths in 2015. Read More

More than 30 years ago, a group of academic and community physicians in Indiana launched the Hoosier Oncology Group (or the “HOG”) as a new model for academic and community collaboration in clinical cancer research.

John McClean, MD, a medical oncologist in Galesburg, Ill., was one of the earliest and most enthusiastic community physicians to join the group. Beginning his own practice around the same time as the HOG’s founding, McClean remained active with the organization throughout his career, until his retirement this year. Read More

The Indiana Department of the Veterans of Foreign Wars Auxiliary (formerly known as the Ladies Auxiliary to the VFW) recently donated more than $14,500 to Hoosier Cancer Research Network. The generous gift is just one example of the VFW Auxiliary’s long-standing support for cancer research.

For more than 100 years, the VFW Auxiliary has served American veterans and active duty service members through a variety of programs, including Cancer Aid and Research. Each of its 4,500 local auxiliaries participates in raising funds toward the program. With more than 465,000 members nationwide, the impact is significant. Read More

Columbus North High School in Columbus, Ind., will host the 2015 Courage to Climb concert on Saturday, Aug. 15, at 7:00 p.m. in the high school’s Erne Auditorium. The annual benefit concert — tickets are $15 at the door — honors Columbus North choir director and cancer survivor Janie Gordon.

Diagnosed with breast cancer in 2009, Gordon broke the news to her students during rehearsal for their summer musical production. Despite their shock, three students wanted to do something to help. They secretly planned a benefit concert in honor of Gordon and named the event “Courage to Climb,” based on a motto Gordon had adopted for her battle against cancer. She was just beginning chemotherapy when the concert was held. “It was an incredibly spirit-lifting experience that really helped pull me through,” she recalls. Read More

Those who follow the trends in modern cancer research know we have entered a new era of discovery. The old strategy of indiscriminately attacking the body to rid it of cancerous cells is giving way to more targeted approaches to treating disease.

E. Gabriela Chiorean, MD, associate professor of medicine at the University of Washington School of Medicine and recipient of the 2014 Danny Danielson Translational Innovation Award, has been steadily gathering tumor samples and blood through clinical studies she has conducted. Biospecimens such as these, collected from consenting patients, are crucial for investigators to learn more about the biomarkers that fuel the development of specific cancers.

Correlative studies built around these biospecimens can help scientists learn why some patients respond to treatment while others do not, and in turn, better predict which patients will be good candidates for specific therapies. Read More

Hoosier Cancer Research Network, a nonprofit cancer research organization in Indianapolis, recently welcomed Annette Moore, MD, as a member of its board of directors.

A medical oncologist/hematologist at Community Howard Regional Health in Kokomo, Ind., Moore earned her medical degree from the University of Mississippi and completed her internal medicine residency and fellowship in hematology/oncology at the Indiana University School of Medicine. Read More