An ongoing alliance between the USC Norris Comprehensive Cancer Center and Hoag Family Cancer Institute at Hoag Memorial Hospital Presbyterian in Newport Beach has expanded to include a joint Phase I/early therapeutics clinical trial program. The program recently activated its first joint clinical trial, one of many planned in a relationship that will benefit both institutions and cancer patients throughout Southern California.

Rohit Varma, MD, MPH, interim dean of the Keck School of Medicine of USC and director of the USC Roski Eye Institute, said, “We are pleased to be able to enter into this phase of our alliance with Hoag as it will be beneficial to all aspects of clinical care and research for USC Norris, the Keck School and Keck Medicine as a whole.”

Anthony El-Khoueiry, MD, director of the Phase I Program and medical director of the Clinical Investigations Support Office at USC Norris, is enthusiastic about what the commencement of this program will mean for everyone involved.

“If these trials are only available at academic medical centers like ours, where patients have to drive for 40, 50, 60 miles,” he explains, “many patients do not have the opportunity to participate for logistical and sometimes financial reasons. The idea is to bring these opportunities to the Orange County community.”

The spectrum of early phase trials that are planned to open at USC Norris and Hoag under this alliance will offer a broad range of innovative and cutting-edge therapies to patients, including new drugs that stimulate the immune system for immunotherapy trials; drugs that target cancer stem cells; and others that act to reprogram genes in the tumor, known as epigenetic therapy.

Burton Eisenberg, MD, professor of clinical surgery at the Keck School, executive medical director of Hoag Family Cancer Institute and Grace E. Hoag Executive Medical Director Endowed Chair, and Diana Hanna, MD, assistant professor of medicine at the Keck School, provide oversight for the Phase I clinical trials at Hoag as part of the collaboration.

Stephen Gruber, MD, PhD, MPH, director of the USC Norris Comprehensive Cancer Center noted, “This is another great step for our patients in Orange County and our clinical trial program. Dr. El-Khoueiry and Dr. Eisenberg have done a great service through this alliance to enhance our terrific collaboration and to bring innovation to the community.”

El-Khoueiry goes on to note that this also greatly benefits the researchers at USC Norris, as it broadens the number of available qualified participants in the study.

“In the era of precision medicine, the nature of Phase I trials has changed,” El-Khoueiry said. “In the case of Phase I trials evaluating targeted agents against specific genetic alterations in the tumor, we have to screen a large number of patients to find the ones who qualify and would hopefully derive the most benefit.”

The idea is to tailor the therapy to the individual patient and therefore maximize the benefits while minimizing the chance of being exposed to therapies that do not help and cause unnecessary side effects.

This first study is a follow-up to an initial Phase I trial that studied the compound sEphB4-HSA as a single drug therapy. Parkash Gill, MD, professor of medicine and Renette and Marshall Ezralow Family Chair in Cancer Therapeutics, developed the compound. This new trial will study the effects of three different chemotherapy combinations containing sEph4B4-HSA on patients with pancreatic, biliary, non-small cell lung and head and neck cancers.

Researchers will look at the safety of these combinations, but also will look at the early efficacy, to see if the combination of drugs tested here perform better than chemotherapy has on its own.

El-Khoueiry concluded by saying that this is a unique alliance that would not have happened without the support of the leadership at both USC and Hoag.

“There is a true commitment on both sides to bring the best that an academic comprehensive cancer center has to offer and merge it with the high caliber clinical care that a distinguished community hospital provides,” he explained. “Ultimately, the synergy between our institutions will contribute to the mission of the USC Norris to make cancer a disease of the past.”

by Amanda Busick