MANHASSET, N.Y.—Nearly all people who develop high-grade gliomas will have regrowth of their tumors at some point, even after surgery, chemotherapy and radiation therapy. Looking to harness the potential of non-invasive ultrasound technology, clinicians at Northwell Health and clinical trial investigators at The Feinstein Institutes for Medical Research have begun to participate in the Alpheus™ Medical, Inc phase 1 clinical trial and enrolled its first set of patients at North Shore University Hospital (NSUH).
“For people living with recurrent brain tumors, new options are long overdue”
There are few therapeutic options to treat these recurrences for many patients diagnosed with high-grade gliomas, including glioblastoma. This multi-site clinical trial looks to study the safety and optimal dosage of an investigational novel sonodynamic therapy (SDT) platform, which targets solid body cancers through ultrasound.
“For people living with recurrent brain tumors, new options are long overdue,” said Michael Schulder, MD, director of the Brain Tumor Center at Northwell Health’s Institute for Neurology and Neurosurgery, a professor in the Feinstein Institutes’ Institute of Molecular Medicine, and principal investigator on the clinical trial. “We are eager to offer this new clinical trial to participants and are grateful for their participation so that we can study this potentially beneficial therapy.”
Yehuda Haber, 62, was one of the first patients to enroll in the trial and undergo treatment at NSUH and the first with his type of brain tumor. Diagnosed 20 years ago with oligodendroglioma, Mr. Haber, a former Israeli Navy SEAL, was treated with radiation and oral chemotherapy. Three years ago, he was referred to Dr. Schulder for treatment with laser interstitial thermal therapy (LITT), an innovative technology to treat small tumor growths. He has had four of these procedures, each of which was successful. However, Dr. Schulder advised him that LITT alone would not be a long-term solution. On October 12, Mr. Haber enrolled in the Alpheus clinical trial, which is aimed at treating the whole tumor.
“I never expected my brain tumors to come back, but when they did, I knew I didn’t want to go through the painful radiation and chemo treatment again,” said Mr. Haber. “When Dr. Schulder told me about this new trial, I didn’t hesitate to sign up. I hope this treatment works for me and others fighting for their lives. Nothing can keep me down!”
The non-invasive drug-device combination treatment targets cancer cells throughout the entire brain hemisphere using low-intensity, large-field ultrasound. The method can be done in an outpatient setting, allows for repeat applications, and does not require imaging during the session. The trial plans to enroll up to 33 patients with high-grade gliomas, including glioblastomas, across three sites across the country.
“Clinical trials to assess safety and effectiveness are a pivotal step before new medical technology can advance into widespread use,” said Kevin J. Tracey, MD, president and CEO at the Feinstein Institutes for Medical Research and Karches Family Distinguished Chair in Medical Research. “Dr. Schulder’s clinical research on brain tumors produces essential new knowledge to guide future therapeutic strategies.”
Alpheus Medical is the sponsor of the trial. For more information, go to: www.clinicaltrials.gov/ct2/show/NCT05362409
About the Feinstein Institutes
The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.