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Trial Testing Ultrasound, Chemo for Brain Tumors

Brain tumor graphic

(National Science Foundation)

16 Dec. 2020. A clinical trial is underway assessing an implanted ultrasound device with chemotherapy to treat glioblastoma, an aggressive form of brain cancer. The study enrolled its first participant at Northwestern University medical center in Chicago, testing the SonoCloud-9 ultrasound device in combination with the chemotherapy drug Abraxane, made by Bristol Myers Squibb.

Researchers led by Adam Sonabend, professor of neurosurgery at Northwestern, are seeking better therapies for glioblastoma, an aggressive brain cancer that affects astrocyte or glial cells supporting neurons or nerve cells in the brain. Glioblastoma is often difficult to treat, where usually the best hope is to slow progression of the disease with radiation or chemotherapy. Survival from initial tumors is typically 15 months and those with recurring glioblastoma usually survive for less than a year.

A key problem with chemotherapy as a treatment for glioblastoma is the the inability of most chemotherapy drugs to cross the blood-brain barrier. That barrier acts as a safety measure to protect the brain from foreign substances crossing from the blood stream while allowing nutrients to flow through. Blood vessels in the brain form a support network for brain functions, with tightly-packed cells lining blood vessels. But, as a result, the blood-brain barrier keeps out drugs to treat neurological conditions and cancer.

The SonoCloud-9 device, made by medical device developer CarThera in Paris, is designed to be implanted in the skull and emit ultrasound waves to temporarily disrupt the blood-brain barrier. The device sits on the connective-tissue membrane covering the brain, just under the skin. A receptacle on the SonoCloud-9 receives a needle through the skin layer that generates ultrasound waves to produce micro-bubbles for opening the blood-brain barrier. The inserted needle also provides power for producing ultrasound, thus eliminating an internal power source.

Abraxane is a formulation of the generic chemotherapy drug paclitaxel used to treat several solid tumor cancers. Sonabend and colleagues already tested the combination of ultrasound and chemotherapy in lab mice, while a team from CarThera and French institutions evaluated the safety of a SonoCloud device alone in glioblastoma patients. Findings from both studies suggest the combination of ultrasound and chemotherapy is a feasible treatment for brain tumors.

The early- and mid-stage clinical trial is enrolling 39 glioblastoma patients. The SonoCloud-9 device is implanted after the tumor is removed in surgery, with the first chemotherapy delivered immediately. The first participants are receiving escalating doses of Abraxane to determine a safe dose with the SonoCloud-9 device, with concentrations of the drug measured in brain tissue biopsies.

After a safe dose level is determined, remaining participants will be evaluated for continuing adverse effects from the treatments as well as one-year survival rate. The study team is also looking for tumor shrinkage in the case of residual disease and measurement of circulating cancer DNA, evidence of cancer cells spreading through the blood stream.

“This trial will extend the safety data for the use of the SonoCloud-9 with additional therapies,” says Frederic Sottilini, CarThera’s CEO in a company statement emailed to Science & Enterprise. “This means glioblastoma patients can be treated with a wider range of therapies using the device and, in the future, receive a therapy that is optimally selected for their particular tumor.”

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