Joseph M. Sanzari Children’s Hospital Offers New Clinical Trial for Children and Young Adults Diagnosed with Aggressive or Recurrent Brain Tumor
July 06, 2022
Hospital Among More than a Dozen in the U.S. and World to Offer Clinical Trial through Pacific Pediatric Neuro-Oncology Consortium Membership
Hackensack Meridian Children’s Health is one of only a dozen pediatric networks in the country participating in a trial studying the treatment of an aggressive cancer of the brain. Joseph M. Sanzari Children’s Hospital at Hackensack University Medical Center — a member of the global Pacific Pediatric Neuro-Oncology Consortium (PNOC) research group — is participating in a PNOC clinical trial for children and young adults with recurrent or progressive high-grade glioma (HGG), an aggressive, fast-growing type of brain tumor. The hospital is one of only 12 centers in the U.S., and the only center in the New York metropolitan area, to offer this trial.
The randomized, double-blinded, placebo-controlled clinical trial will evaluate local and systemic immunological changes, and the safety and efficacy of checkpoint inhibition therapy (CPIT) when delivered prior to surgery. CPIT works by “releasing the switches” — or checkpoints — that prevent the immune system’s T-cells from identifying and attacking cancer cells.
Trial participants will be randomly divided into three groups. Group A will receive a one-time dose of immunotherapy medication nivolumab and placebo prior to surgery. Group B will receive a one-time dose of nivolumab and ipilimumab, another immunotherapy medication,
prior to surgery. Group C will receive a one-time dose of placebo and ipilimumab prior to surgery.
After surgical tumor resection, all patients will receive three doses of nivolumab and ipilimumab administered every three weeks, followed by nivolumab every two weeks.
“High-grade gliomas account for approximately 10 percent of all brain tumors in children, and more research is needed to identify treatments that may improve long-term survival rates,” Derek Hanson, M.D., chief, Pediatric Neurology-Oncology, Joseph M. Sanzari Children’s Hospital at Hackensack University Medical Center and PNOC principal investigator. “Immunotherapy has been shown to be a promising treatment for other types of cancer, and
our goal with this study is to learn more about how and when immunotherapy could be used to provide new hope for children diagnosed with HGG.”
“Our participation in PNOC provides our patients and families with access to some of the most promising, leading-edge brain tumor clinical trials in the world,” said Judy Aschner, M.D., physician-in-chief, Pediatrics, Hackensack Meridian Children’s Health. “These groundbreaking clinical trials advance the field of neuro-oncology and pave the way for the development of life-saving brain tumor treatments for children.”
“This is an important trial aimed at advancing treatment for a devastating illness,” said Ihor Sawczuk, M.D., FACS, Hackensack Meridian Health’s president of Academics, Research and Innovation, and also associate dean of Clinical Integration and professor and chair emeritus of Urology at the Hackensack Meridian School of Medicine. “We're glad to be one of the few sites around the country helping to move the work forward.”