The first patient has been treated in a new phase I/II clinical trial for patients with recurrent glioblastoma (GBM). Researchers at Northwestern University in Chicago will recruit up to 39 patients to have CarThera’s SonoCloud-9 implanted after surgical removal of the tumor, as it will be used to temporarily open the blood-brain barrier (BBB) prior to the administration of chemotherapy.
This trial has two phases. Phase I will determine the safe dose of Abraxane® – an albumin-bound formulation of paclitaxel – that can be administered after BBB opening with the SonoCloud device. Phase II will use the established safe dose to evaluate the effectiveness of the combination of the drug with the BBB opening of the device after surgical removal of the recurrent GBM. Blood samples for circulating tumor DNA (liquid biopsy) will also be collected before and after each sonication with the CarThera device. This may help researchers understand treatment effects, aiding as a type of diagnostic test to follow for potential tumor progression or recurrence.
Another CarThera Phase I/II clinical trial that is underway at Northwestern University is using a similar study design with the administration of carboplatin. Both studies are for patients with recurrent glioblastoma.
Researchers who are using a variety of ultrasound devices to open the BBB and deliver neurotherapeutics for the treatment of GBMs are currently recruiting for clinical studies at sites in the United States, Canada, Korea, France, and Taiwan.
If you are interested in learning more about this trial, please contact:
Christina Amidei, APN, PhD
Roger Stupp, MD