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John R. Fischer, Senior Reporter | January 26, 2023
Northwell Health and The Feinstein Institutes for Medical Research have enrolled their first patients in the Phase I clinical Alpheus Medical trial on dose optimization for SDT.
Northwell Health and the Feinstein Institutes for Medical Research are participating in a phase I clinical trial to evaluate safe and optimal dose levels of an investigational novel sonodynamic therapy (SDT) platform for treating recurring tumors in patients with high-grade gliomas.
Even after surgery, chemotherapy and radiotherapy, tumors in people with this condition almost always grow back at some point, and there are very few options to treat recurrences for these patients, including those with glioblastoma, an aggressive form of brain or spinal cord cancer.
A noninvasive treatment, SDT utilizes low-intensity, large-field ultrasound and a sonosensitizer to eradicate solid tumors of varying depths. By reducing a target number of cells, the treatment increases the chances of preventing future tumors from regrowing.
Clinicians at Northwell and clinical trial investigators at the Feinstein Institutes for Medical Research have enrolled their first set of patients at North Shore University Hospital, one of three U.S. sites where the Alpheus Medical sponsored research will be conducted. Up to 33 people with high-grade gliomas, including glioblastoma, will participate.
“Clinical trials to assess safety and effectiveness are a pivotal step before new medical technology can advance into widespread use,” said Dr. Kevin Tracey, president and CEO at the Feinstein Institutes for Medical Research and Karches Family Distinguished Chair in Medical Research.
The aim of the study is to treat entire tumors, with the treatment targeting cancer cells throughout the entire brain hemisphere. It can be performed in outpatient settings, enabling repeat applications and eliminating the need for imaging during the session.
Among the first patients enrolled is Yehuda Haber, 62, who was also the first to be treated in the trial for a type of brain tumor called oligodendroglioma. Diagnosed 20 years ago, he underwent radiation and oral chemotherapy, as well as four laser interstitial thermal therapy (LITT) procedures to treat small tumor growths before being referred for the study by Dr. Michael Schulder, principal investigator for the clinical trial.
“For people living with recurrent brain tumors, new options are long overdue. 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,” said Schulder, director of the Brain Tumor Center at Northwell Health’s Institute for Neurology and Neurosurgery, and a professor in the Feinstein Institutes’ Institute of Molecular Medicine.
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