The Gibbs Foundation Inc. is giving $1.5 million to the University of Louisville over three years to fund additional research staff and faculty time dedicated to clinical trials, increasing capacity for trial participants in the tumor infiltrating lymphocytes program, or TILs.

“We are so very grateful to the Gibbs Foundation for this gift. By allowing the Brown Cancer Center to expand this clinical trial and treat more patients with this innovative therapy, it provides hope for more families who are battling cancer and advances these therapies, potentially benefitting even more cancer patients and families,” said Lori Gonzalez, UofL’s interim president.

In clinical trials at the , therapy known as tumor infiltrating lymphocytes, or TILs, has been shown to be effective in treating advanced melanoma patients, for whom the median survival is only eight months. TILs treatment involves removing one of a patient’s own tumors, preserving, activating and expanding immune cells from the tumor, then administering these immune cells into the patient. As a result of its success in melanoma patients, BCC is expanding the TILs program to test the therapy for the treatment of other cancers.

TILs patients face a long wait time due to the complex and time-consuming nature of the therapy and demands on clinical research staff. The gift from the Gibbs Foundation will allow UofL to hire additional nurses and coordinators and dedicate more of the oncologists’ research time to support TILs, a complex inpatient procedure. The gift is expected to result in the treatment of at least 25 additional patients.

“The Gibbs Foundation Board of Directors has been dramatically impressed with the success of the Brown Cancer Center’s immunotherapy work conceived and spearheaded by Dr. Jason Chesney.�� We look forward to continuing the vision of our founder George Gibbs in helping to facilitate this great effort,” said Ivan J. Schell, Gibbs Foundation board member. “The Gibbs Foundation supports the BCC and its dedicated team of physicians as they gain ground in the search for a cure for all cancers.”  

The Gibbs Foundation Inc. was established in 2014 by George and Betty Gibbs of Louisville. George died in January of pancreatic cancer at age 87. The Gibbs Foundation currently also supports lung health research at UofL through gifts of more than $2.5 million to create and expand the lung research program.

Cancer remains one of the most difficult and deadly challenges in health care, killing more than 600,000 people each year in the U.S. and nearly 10 million worldwide. Kentuckians are affected at a higher rate than residents of any other state. BCC serves more than 26,000 cancer patients every year and has the largest early-phase cancer trials program in the region. BCC is a global leader in the clinical testing of new immunotherapies, treatments that activate the body’s immune system to fight cancer and is an early adopter of these treatments.

“My goal is to help make cancer something that people one day study in history classes instead of medical schools, and I truly believe we are getting closer to that day,” said Jason Chesney, chief of the UofL Division of Medical Oncology and Hematology and director of the Brown Cancer Center. “This gift allows us to increase the number of patients and advance this lifesaving technology.”

The iVAS is a minimally invasive alternative to ventricular assist devices for use in patients with severe heart failure, allowing more mobility and implant without open-heart surgery. The iVAS supports heart function and can be used temporarily while patients await a heart transplant or as a more permanent treatment. UofL is the only site in Kentucky participating in the iVAS trial.

The iVAS is a counterpulsation heart device, assisting the heart by pumping between beats while the heart is resting to increase the flow of blood and oxygen to the heart. Manufactured by the device consists of a balloon-type pump placed in the descending aorta. This pump is inflated and deflated to help move blood through the body. The intra-aortic pump is connected through the skin to an external drive unit. The new technology is an improvement over other heart assist devices such as the left ventricular assist device (LVAD) most significantly in that the iVAS is implanted with a minimally invasive procedure, not requiring open heart surgery.

“The iVAS is put in through a peripheral artery so it does not require opening the chest or placing the patient on a heart-lung machine,” said Slaughter, chair of the Department of Cardiovascular and Thoracic Surgery in the UofL School of Medicine and surgical director of heart transplant and mechanical assist devices for UofL and Jewish Hospital. “Through this clinical trial, we may find additional advantages such as the opportunity for patients to disconnect from the device intermittently. With the VAD, you are always tethered to the device. With the iVAS, you may be able to be untethered or turn it off for short periods,” Slaughter said.

Another benefit, Slaughter said, is patients are not required to be on long-term blood thinners, which can have serious side effects.

Robert Hughes, one of the patients who received the iVAS implanted by Slaughter in Louisville, had a heart attack in May and subsequently learned he had heart failure.

“I finished chemo for leukemia in January. I had gone from 200 pounds to 145 pounds and I was pretty weak,” Hughes said. “Then I had the heart attack on May 17. Afterward I was getting dizzy just standing. I felt like I would faint. It was very unnerving. I didn’t want to get out and do a nosedive at Pic Pac,” Hughes said.

Hughes’s diagnosis was advanced heart failure, but he did not qualify for either a heart transplant or open-heart surgery, so when he was presented with the iVAS as a long-term option, he was ready to participate in the trial. His iVAS was implanted on Aug. 13. Within a few weeks, he was able to go home.

“Since the surgery, I feel stronger and haven’t had dizzy spells. I am gaining my weight back,” Hughes said. “I am very pleased with the outcome. As far as I’m concerned, everything is a plus.”

Hughes said he has been able to get out for trips to the drug store or grocery store without fear of passing out. The external drive unit for iVAS weighs only 8 pounds, permitting patients to be discharged from the hospital to await transplant or continue their lives at home and free to go out in the community.

The goal of the is to determine whether iVAS is as effective as the LVAD. Including the two patients at Jewish Hospital, 70 patients have been implanted with the iVAS device in 12 centers across the United States.��

Learn more about clinical trials at UofL .

Lara MacGregor, who lives with metastatic breast cancer, started in 2012 to provide women undergoing cancer treatment a way to encourage one another by sharing a scarf and a story. In 2015, Hope Scarves established a Metastatic Breast Cancer Research Fund to raise funds to support research and patient care.

For 2019, Hope Scarves has provided a gift of $25,000 to the , with an anonymous match of $25,000 for a total gift of $50,000. The funds are designated to bringing more clinical trials for metastatic breast cancer patients to Louisville.

Kentucky has one of the highest rates of breast cancer in the United States, and Jefferson County has one of the highest rates in Kentucky. Participation in clinical trials is one way to improve outcomes, not only for the patients who participate, but by bringing more and better treatments to market for all patients.

“Participation in clinical trials benefits not only the patients involved in the trial, but the field of cancer treatment in general,” said Beth Riley, MD, deputy director for clinical affairs at UofL’s Brown Cancer Center. “Currently, metastatic breast cancer is not curable with standard treatment. By participating in trials, patients in Kentucky not only have early access to novel drugs or drug combinations, but they are helping physicians and scientists learn more about effective treatments and disease characteristics so we can move closer to a cure for this disease. Clinical trials involvement is vital to improve the lives of cancer patients here in Kentucky and worldwide.” 

One patient who benefited from treatment in a clinical trial at the center is Brenda Craig, a Louisville native who was diagnosed with breast cancer in 2013. After several years in remission, her cancer returned; this time it was stage 4 and more challenging to treat.

“The treatments I was getting were not making me feel good and were not doing anything for my cancer,” Craig said. “When my doctor said, ‘Would you like to try the clinical trial?’ I wanted to live, so I said, ‘Yea! Sure, I’d try it.’”

Her condition improved while she was on the trial treatment, nearly bringing her to remission again. Unfortunately, she had to stop the trial drug when she came down with pneumonia. Nevertheless, she is grateful to have had the opportunity.

“The clinical trial brought me a long way. I was on it 8 to 10 months and I was doing great,” Craig said. She now is on another treatment, but her cancer has remained stable.

Craig said one of her most important missions on her cancer journey is to support others with the disease, a mission shared by Hope Scarves.

“We are human. We cry and we tell our stories to each other. My story helps you and your story helps someone else. We keep it going,” Craig said. “Even if I don’t make it, I hope I can be an example for someone else, that whatever they did for me, it can help someone else.”

MacGregor, a Louisville resident, has seen clinical trials benefit patients at the UofL Brown Cancer Center, and her own treatment includes a drug tested at the center. She wants Hope Scarves’ funds to invigorate that process.

“There is a huge burden to participate in clinical trials that are only available in another city. You have transportation and lodging to consider, and you are away from your home support system – your family and friends – who truly make a difference when you are fighting this disease,” MacGregor said.

By making more trials available in Louisville, not only local women benefit, but also future patients by allowing more people to participate in the trials, advancing medical research more quickly.

“Clinical trials are the future of cancer treatment, not a last resort,” MacGregor said. “These therapies are the next generation of care and may give patients better outcomes, and we are providing these funds to enable more women to have access to them.”

Runners in the Kentucky Derby Festival Marathon and Mini Marathon have raised funds for Hope Scarves as a team, Outrunning Cancer, for the past seven years. In 2015, Hope Scarves presented its first gift to the UofL Brown Cancer Center to support basic research. This year, in addition to UofL, Hope Scarves is providing funds for basic cancer research to Johns Hopkins Medical Center and the Dana-Farber Cancer Center at Harvard University.

“It is our intentional strategy to fund both basic science and patient access to care,” MacGregor said.

Combining the efforts of Norton Cancer Institute and Norton Children’s Hospital, in affiliation with University of Louisville, Norton Children’s Cancer Institute will provide improved access and additional services to care for children fighting cancer. This includes new programs for treating rare tumors and benign blood disorders, such as sickle cell anemia, as well as a revamped program for bone marrow transplants.

In addition to offering new types of care, Norton Children’s Cancer Institute has three primary goals:

• Increase the number of clinical trials offered to patients and gain access to new therapies in their earliest stages
• Develop additional groundbreaking research and cutting-edge technology
• Recruit additional hematology/oncology specialists and medical students to improve patients’ access to care.

“We expect Norton Children’s Cancer Institute to be the beacon of hope for families not just in Metro Louisville, but throughout the entire commonwealth,” said Thomas D. Kmetz, division president, Women’s and Children’s Services and Norton Children’s Hospital. “This collaboration will create an even more unified focus on delivering unparalleled cancer care to children fighting this terrible disease.”

“This is our chance for Louisville to become nationally recognized in the world of pediatric cancer research and gain access to the most cutting-edge clinical trials,” said Joseph M. Flynn, DO, MPH, FACP, executive director and physician-in-chief, Norton Cancer Institute. “We see this affiliation as an opportunity to combine our resources and expertise to give kids the best treatment there is.”

The University of Louisville will provide physician support for Norton Children’s Cancer Institute. Norton Healthcare will commit $1 million to UofL per year for pediatric oncology research and physician recruitment, as well as offer leadership and support staff for the institute.

“The relationship between Norton Children’s Hospital and the University of Louisville leading to the creation of Norton Children’s Cancer Institute is to forge a productive collaboration in the battle against childhood cancer,” said Toni Ganzel, MD, MBA, executive dean for the UofL Health Sciences Center. “The within the UofL School of Medicine has been part of one of medicine’s greatest successes in the sharp rise in survival rates of children with cancer.

“With more survivors, there is an urgent need to understand the effect of treatments on the entire body, not just the cancer. With a multidisciplinary approach and comprehensive treatment and support services, Norton Children’s Cancer Institute will have at its core a sense of urgency not only in bringing newer therapies to accelerate childhood cancer survival rates but also to intently focus on the survivors and alert them to potential risks, including serious and sometimes life-threatening complications, as late effects of cancer treatments.”

Within Norton Children’s Cancer Institute, inpatients will continue to be treated at the Addison Jo Blair Cancer Care Center in Norton Children’s Hospital. For outpatients, the institute will occupy the fourth floor of the University of Louisville’s new 170,000-square-foot pediatric medical office building at 401 E. Chestnut St. The facility is still under construction and is expected to be completed in July 2018.

With more than 8,000 pediatric cancer visits each year, Norton Children’s Hospital is home to the country’s oldest children’s oncology program, continually accredited by the American College of Surgeons’ Commission on Cancer (CoC) since 1959. As the teaching facility for the University of Louisville School of Medicine Department of Pediatrics, Norton Children’s Hospital is dedicated to its mission of serving the children of this community and region.

Learn more about the Norton Children’s Cancer Institute .

Areas receiving grants are pediatric cardiac regenerative medicine, pediatric surgery research, the Kosair Charities Pediatric Clinical Trials Unit, the UofL Autism Center at Kosair Charities, the Child and Adolescent Health Research Design and Support Unit, and the Kosair Children’s Hospital Research Institute.

“Research is vital to advancing the care we, as partners, can provide to children,” said Steven T. Hester, MD, MBA, system senior vice president and chief medical officer, Norton Healthcare. “The pediatric specialists at the University of Louisville are doing work that can help us provide even better care and, hopefully, cures.”

“We appreciate the funding provided by Norton Healthcare to further our work in understanding and ultimately curing diseases and conditions that affect children,” said Gregory C. Postel, MD, interim executive vice president for health affairs, University of Louisville. “At UofL, we have set an ambitious yet achievable agenda in pediatric research that will advance medical knowledge and provide novel and innovative treatments for the children of Kentuckiana and beyond.”

“We see firsthand the benefits that research provides to children,” said Thomas D. Kmetz, division president, Women’s and Children’s Services and Kosair Children’s Hospital. “Supporting this research agenda is incredibly important not just to children, but also in continuing to attract additional pediatric specialists to Louisville.”

The $1.25 million provides one year of funding to the six research areas:

• $100,000 for pediatric cardiac regenerative medicine, led by Bradley B. Keller, MD, for research focusing on identifying the biomechanical origins of congenital heart disease and the development of implantable engineered cardiac tissues for repair and restoration using patient-derived human pluripotent stem cells. The goal of these studies is to repair and regenerate damaged heart muscle as an alternative to cardiac transplantation.
• $100,000 for the pediatric surgery research lab, led by Mary E. Fallat, MD, to support research in surgical techniques and outcomes, trauma practices and necrotizing enterocolitis, a disease that affects mostly the intestine of premature infants where the wall of the intestine is invaded by bacteria that cause local infection and inflammation that can ultimately destroy the bowel wall. Research in this area directly impacts the care children and neonates receive when they need surgical services.
• $100,000 for the Kosair Charities Pediatric Clinical Research Unit, led by Janice E. Sullivan, MD, to support the unit’s medication, quality improvement and device clinical trials. The goal of this unit is to improve health care provided to children through development of new or improved treatment practices and evaluation and approval of medical devices or medications for children.
• $250,000 for the UofL Autism Center at Kosair Charities led by Gregory N. Barnes, MD, PhD, to support the Precision Medicine Initiative in Autism Spectrum Disorders. The goal of this study is to use a child’s DNA to develop individualized treatment approaches to better restore the function of neural circuits in the brain, thereby improving behavior and cognitive skills.
• $300,000 for the Child and Adolescent Health Research Design and Support Unit led by Charles R. Woods Jr., MD, to support research projects around overprescribing of psychiatric medications and antimicrobial agents in children, as well as improving data availability to frontline state workers in the foster care system. The goal of this research unit is to improve the effectiveness, quality, safety and delivery of health care and prevention/health promotion services to children.
• $400,000 for the Kosair Children’s Hospital Research Institute led by Lu Cai, MD, PhD, for support in research programs in the areas of diabetes- and obesity-related multi-organ diseases, including cardiovascular diseases, pulmonary diseases, neurobiological and carcinogenic susceptibility, molecular and cellular mechanisms and potential interventions. The focus of the institute is on basic and translational research, bringing these programs forward as quickly as possible from the laboratory bench to the patient’s bedside.

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