Hoag Family Cancer Institute Leads National Effort to Combat Glioblastoma with Two New Clinical Trials

Hoag physicians testing promising options for the diagnosis and treatment of glioblastoma (GBM), the deadliest form of brain cancer

NEWPORT BEACH, Calif., Jan. 8, 2025 /PRNewswire/ -- Leading the forefront of neuro-oncology and neuroscience innovation, Hoag Family Cancer Institute and Hoag's Pickup Family Neurosciences Institute are involved in two clinical trials for the diagnosis and treatment of glioblastoma (GBM), a brain tumor with a 5% five-year survival rate.

The LIBERATE study (NCT05383872), sponsored by INSIGHTEC, evaluates the use of Focused Ultrasound (FUS) as a way to temporarily open blood-brain barrier (BBB), a protective inner layer of the blood vessels in the brain, to enable liquid biopsies in patients with GBM. Liquid biopsy is an emerging method of collecting and analyzing biomarkers through a simple blood test instead of an invasive surgical biopsy, and the information can be used for more reliable diagnosis and to plan treatment options. For GBM or brain tumor, however, biomarkers are not released into the blood stream because of the BBB. Opening the BBB using FUS may provide a safer and non-invasive approach to brain tumor liquid biopsies. Hoag Family Cancer Institute is one of only 17 sites throughout the U.S. to participate in this trial. Simon Khagi, M.D., Medical Director of Neuro-Oncology at Hoag Family Cancer Institute is serving as the principal investigator of the LIBERATE trial at Hoag.

Focused Ultrasound is a noninvasive therapeutic technology with the potential to transform the treatment of many medical conditions by using sound waves, guided by MRI imaging to target tissue deep in the body without incisions or radiation. Hoag acquired Focused Ultrasound technology in part through philanthropic funding provided by Hoag Innovators, a group of philanthropists, entrepreneurs, and community leaders dedicated to catalyzing innovation at Hoag.

"Focused Ultrasound has untold potential," says Dr. Khagi. "This approach of opening BBB may allow for targeted delivery of treatment to specific areas in the brain, potentially enhancing treatment outcomes in the future. Low frequency FUS can open the blood-brain barrier for up to 24 hours. During that time, two things can happen: fluid comes out, and we can test it for biomarkers; and treatment can go in. This means that we can effectively deliver treatment to target specific areas in the brain. Most chemotherapy and immunotherapy are unable to fully penetrate the brain to kill brain tumors. Opening the blood-brain barrier would be revolutionary in future clinical trials of cell therapy and immunotherapy."

Hoag's Pickup Family Neurosciences Institute is already using FUS for people whose essential tremor or tremor-dominant Parkinson's disease has not responded to medication.

"We are seeing immediate results, with no downtime after the procedure," said Christopher M. Duma, M.D., neurosurgeon specialist. "Thanks, in part, to philanthropic support, we are able to purchase the FUS machine, and offer this non-invasive treatment to our patients. We are very proud to lead such innovative treatment approaches at Hoag."

"Hoag's dedication to innovation has extended lives and improved the quality of life for the community," said Dr. Robert Louis, who is the Empower360 Endowed Chair in Skull Base and Minimally Invasive Neurosurgery, Chief of the Division of Neurosurgery and Director of the Pituitary & Skull Base Tumor Program in Hoag's Pickup Family Neurosciences Institute. "The use of Focused Ultrasound is just one of many examples of Hoag's promise to our community to provide the treatment options of tomorrow to our patients today," he said.

Hoag Family Cancer Institute has also been selected as one of two study sites for the QUILT 3.078 clinical trial, which is studying the investigational immune system enhancing agent N-803 and PD-L1 t-haNK cell therapy both from ImmunityBio, Inc., along with Bevacizumab (Avastin®) for recurrent or progressive glioblastoma (NCT06061809). The Phase 2 study is designed to determine if the combination of N-803, which is currently approved for non-muscle-invasive bladder cancer carcinoma in situ, PD-L1 t-haNK, and Bevacizumab, an immunotherapy currently approved for GBM is safe and slows down the progression of the disease. Study participants receive Bevacizumab and PD-L1 t-haNK intravenously and N-803 is administered subcutanesously via an injection in the abdomen twice a month for up to 18 months.

Hoag Family Cancer Institute is involved in a variety of immunotherapy and cell therapy trials evaluating "natural killer," or NK cell therapy, which has shown promise to be beneficial in treating solid tumors.

"We are very proud to be one of only two sites in the world running this study using modified natural killer cells for glioblastoma patients," said Dr. Khagi. "We've seen promising results in treating other cancers with this innovative option and are hopeful that it will provide new hope to our patients."

Hoag physician leaders believe that the future of GBM treatment will be a multi-modal approach which may include FUS, combined with cell therapy and Optune Gio, a device that generates an electrical field to stop cancer cells from dividing. This approach requires a collaborative team of multidisciplinary experts who are able to work together to advance diagnosis and treatment with patients' best outcomes in mind.

Hoag's unique "privademic" model of care, which combines the medical expertise and innovation of a major academic institution with the personalized approach of a private healthcare system sets the hospital apart. The combination of innovation and ability to move quickly brings groundbreaking trials like these to the Orange County community.

"We have the expertise here at Hoag that allows us to decide on the best approach for each individual patient," Dr. Khagi said.

For information about these clinical trials, please email [email protected] or call 949-764-4577.

ABOUT HOAG

Hoag is a nonprofit, regional health care delivery system in Orange County, California. Delivering world-class, comprehensive, personalized care, Hoag consists of 1,800 top physicians, 17 urgent care facilities, 11 health & wellness centers, and two award-winning hospitals. Hoag offers a comprehensive blend of health care services that includes seven institutes providing specialized services in the following areas: cancer, digestive health, heart and vascular, neurosciences, spine, women's health, and orthopedics through Hoag's affiliate, Hoag Orthopedic Institute, which consists of an orthopedic hospital and four ambulatory surgical centers. Hoag is the highest ranked hospital in Orange County by U.S. News & World Report and the only OC hospital ranked in the Top 10 in California, as well as a designated Magnet^® hospital by the American Nurses Credentialing Center (ANCC). For more information, visit hoag.org.

SOURCE Hoag