Safety of BBB Opening With the SonoCloud (SONOCLOUD)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma. [ Time Frame: 6 months ]
- Maximum tolerated dose of ultrasound with the SonoCloud system for transient disruption of the BBB. [ Time Frame: 6 months ]
- Quantification of the disruption of the BBB by the SonoCloud system using dynamic T1 contrast-enhanced MRI. [ Time Frame: 6 months ]
- Progression-free survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
- Overall survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: SonoCloud + carboplatin
SonoCloud : dose escalation Carboplatin : 6 cycles - individual dose determination according to renal function and AUC
SonoCloud : dose escalationDrug: Carboplatin
Carboplatin : 6 cycles - individual dose determination according to renal function and AUC
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02253212
|Contact: Alexandre C Carpentier, MD, PhD||001 33 firstname.lastname@example.org|
|Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department||Recruiting|
|Paris, France, 75013|
|Contact: Alexandre C Carpentier, MD, PhD|
|Principal Investigator:||Ahmed Idbaih, MD, PhD||Assistance Publique - Hôpitaux de Paris|