About the Phase 1 Trial
Trial Name: A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy in Patients With Recurrent High Grade Glioma
ClinicalTrials.gov Identifier: NCT05362409
Sponsor: Alpheus Medical, Inc.
Recruitment Contact: Alpheus Medical, (612) 234-4009, email@example.com
Completion Date: April 2024
The first 3 patients have been treated in the multi-center phase 1 clinical trial (NCT05362409) assessing the safety and optimal dosage of 5-aminolevulinic acid (5-ALA) plus CV01 delivery of ultrasound for sonodynamic therapy (SDT) in patients with recurrent high-grade glioma, according to Alpheus™ Medical, Inc.1
"Conventional therapy options for patients with high-grade glioma, including glioblastoma, are limited and innovation in the field has too long been stagnant, leaving patients with poor outcomes and significant tradeoffs in quality of life. By non-invasively targeting and eradicating tumor through the entire brain hemisphere, Alpheus' novel SDT platform represents a potential paradigm shift in the fight against this disease," said Michael Schulder, MD, director of the Brain Tumor Center at Northwell Health's Institute for Neurology and Neurosurgery, in the press release. "We are excited to be part of this important clinical trial and look forward to following these patients as we evaluate the therapy."
An estimated 33 patients will be enrolled in the multi-center, phase 1 study of 5-ALA combined with CV01 delivery of ultrasound for SDT in patients with recurrent high grade glioma.2
Those enrolled will be aged 18 years and older with histopathologically confirmed diagnosis of high-grade glioma and radiographic evidence of recurrence after prior therapy with radiotherapy. Patients are required to have a WHO performance status of ≤ 2 at screening, unifocal or multifocal tumor confined to the supratentorial compartment, have adequate bone marrow and organ function, coagulation function, and any toxicities associated with prior anti-cancer therapy must be resolved to the patient's baseline level or ≤ grade 1.
Those with primary infratentorial or brainstem tumors and spinal cord tumors, Bihemispheric disease or tumors that involve the bilateral corpus callosum, hypersensitivity to 5-ALA or porphyrins, and who have the inability to undergo MRI or receive gadolinium-based contrast agents will be excluded from the trial. Further, patients with acute or chronic types of porphyria, gastrointestinal disorder that negatively affects absorption, known active hepatitis B or C, or human immunodeficiency virus infection, are ineligible for enrollment. Women who are pregnant or breastfeeding are also not eligible to be enrolled.
In this first-in-human study, patients will be administered 5-ALA orally at a dose of 20 mg/kg every 4 weeks and CV01-delivered ultrasound every 4 weeks.
Investigators are assessing the primary end points of safety and tolerability, including the incidence of adverse events, and the maximum tolerated dose. Secondary end points of the trial include the assessment of overall response rate, duration of response, overall survival, and progression-free survival.
Currently, patients with high-grade gliomas, including glioblastomas, are being enrolled across 3 sites, including Northwell Health's North Shore University Hospital and Dent Neurologic Institute in New York, and Washington University in St. Louis, Missouri.
"The heterogeneous, diffuse nature of gliomas behind the blood-brain-barrier is preferably treated with a repeatable, large-field therapy that can extend beyond the borders of the visible tumor to eradicate the highly invasive cancer cells," added Tanner M. Johanns, MD, assistant professor of Medical Oncology at Washington University School of Medicine in St. Louis, in the press release. "Alpheus' non-invasive SDT therapy aims to overcome both challenges with a safe, repeatable therapy that targets only cancer cells."
Alpheus Medical treats first patients in first-in-human clinical trial for novel high-grade glioma brain cancer treatment. News release. Alpheus™ Medical, Inc. November 10, 2022. Accessed November 10, 2022. https://prn.to/3DUUOX5
Study to evaluate 5-ALA combined with CV01 delivery of ultrasound in recurrent high grade glioma. ClinicalTrials.gov. Updated October 28, 2022. Accessed November 10, 2022. https://www.clinicaltrials.gov/ct2/show/NCT05362409?term=NCT05362409&draw=1&rank