Glioblastoma Clinical Trial
Official title:
A Study to Evaluate the Safety of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SonoCloud Implantable Device in Patients With Recurrent Glioblastoma Before Chemotherapy Administration
PURPOSE: The purpose of this study is to determine whether transient opening of the
blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is
safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery
of carboplatin-based chemotherapy.
STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior
to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of
the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to
carboplatin-based chemotherapy and increase progression-free and overall survival in patients
with recurrent glioblastoma.
For patients with recurrent malignant gliomas, who have already been treated by a combination
of surgery, radiation therapy and/or chemotherapy, few treatment options currently exist.
Salvage therapies typically consist of systemic administration of chemotherapy agents, which
have been shown to have limited effectiveness as median survival in this patient group is
currently only 6 months.
One limitation to the efficacy of systemic chemotherapy in the treatment of brain tumors is
the blood-brain barrier (BBB). To enhance the delivery of systemically administered
chemotherapy agents to brain tumors, an implantable ultrasound device was developed that can
be used to temporarily disrupt the BBB. Delivery of pulsed ultrasound, in combination with an
ultrasound contrast agent, has been shown to temporarily disrupt the BBB for a duration of
more than 6 hours and allow for a significantly increased penetration of systemically
administered chemotherapy drugs in pre-clinical studies.
This study will evaluate the safety of temporary disruption of the BBB during carboplatin
chemotherapy delivery in patients with recurrent glioblastoma. This study will also evaluate
the maximum tolerated dose of ultrasound that can be used to disrupt the BBB.
The use of dynamic contrast-enhanced MRI will be evaluated for determining the extent and
magnitude of BBB opening. Clinical efficacy (Survival) and radiological efficacy (Progression
Free Survival) will also be evaluated as secondary endpoints.
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