The Sonodynamic Brain Cancer Trial
A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy(SDT) in Patients With Recurrent High Grade Glioma (HGG)
High-grade gliomas are the most commonly occurring primary CNS tumors in adults. The investigational product in this clinical study is a drug-device combination product consisting of 5-ALA HCl oral solution and the CV01 ultrasound delivery device. 5-ALA will be administered as a sonosensitizer prior to CV01-delivered ultrasound and will be re-administered every 4 weeks prior to CV01 ultrasound delivery. The CV01 device will deliver non-ablative, low-intensity ultrasound to deep regions of the brain to induce apoptosis of cancer cells.
This FIH study will include 3 parts. The first part will evaluate escalating durations of ultrasound delivery with CV01. The second part will further evaluate the recommended duration as determined during the first part. The third part will be the surgical group. This study will enroll up to 48 patients in total.
Northwell Brain Tumor Center
|300 Community Dr, Manhasset, NY 11030, USA|
Principal Investigator: Dr. Michael Schulder
Washington University Medical Center
|St. Louis, MO, USA|
NOT YET ENROLLING
Compassionate Use at Alpheus
At this time, Alpheus does not provide access to the CV01 Sonodynamic Therapy system outside of clinical trials. Alpheus’ priority is to conduct clinical trials in order to collect the necessary data to determine the potential risks and benefits of treatment with the CV01 Sonodynamic Therapy system, with the intent to make this treatment more broadly available to patients.
In rare cases, Alpheus may provide access to the CV01 Sonodynamic Therapy system if the patient suffers from a serious or life-threatening illness, has exhausted all other treatment options, and there is a reasonable expectation of benefit over risk as defined in our Expanded Access Policy. As mentioned in the policy, a treating physician who has experience with the CV01 Sonodynamic Therapy system may apply for access on behalf of their patient, if the physician meets all criteria specified within the policy and the patient meets all the criteria specified for consideration of participation. Requests should be sent to email@example.com and will generally be replied to within 5 business days of receiving all the pertinent information.