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Safety of BBB Opening With the SonoCloud (SONOCLOUD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253212
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Glioma Brain Tumor Device: SonoCloud Drug: Carboplatin Phase 1 Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : July 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: SonoCloud + carboplatin
SonoCloud : dose escalation Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC
 Device: SonoCloud
SonoCloud : dose escalation

Drug: Carboplatin
Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC


Outcome Measures
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Primary Outcome Measures :
  1. Safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Maximum tolerated dose of ultrasound with the SonoCloud system for transient disruption of the BBB. [ Time Frame: 12 months ]
  2. Quantification of the disruption of the BBB by the SonoCloud system using dynamic T1 contrast-enhanced MRI. [ Time Frame: 12 months ]
  3. Progression-free survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
  4. Overall survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age greater than 18 years.
  • Subjects with recurrent glioma who have failed standard therapy with surgery and/or treatment with radiation and temozolomide.
  • Patient eligible for Carboplatin-based chemotherapy
  • Contrast-enhanced tumor less than 35 mm in diameter
  • No risk of cerebral herniation
  • Able to tolerate pre/post procedure steroid treatment
  • Social security affiliated (in France)
  • Able and willing to give signed and informed consent
  • Normal biological status
  • Hemoglobin ≥ 10 g/dl
  • Platelets ≥ 100000/mm3
  • Neutrophils ≥ 1500/mm3
  • Normal creatine clearance ≥ 60ml/mn
  • ASAT < 3 N
  • ALAT < 3 N
  • Normal Bilirubin Level < 1.5 N
  • Alkaline Phosphatase < 3 N
  • INR < 1.5
  • Prothrombin Level ≥ 70%

Exclusion criteria:

  • Allergic to Iodine, Gadolinium, Xylocain
  • Contra-indications to echographic contrast agent (microbubbles)
  • Severe Renal insufficiency
  • Hepatic insufficiency
  • Possible toxic treatment for CNS
  • Previously infected surgical field
  • Uncontrolled epilepsy
  • MRI contra-indications
  • Hemostasis troubles thrombopenia <75.000, TP <60%, INR >1.5, anti-platelet or anticoagulant therapy on-going)
  • Active phlebitis or active pulmonary embolism
  • Pregnant or currently breast-feeding
  • Patients under judicial protection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253212


Locations
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France
Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Ahmed Idbaih, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02253212    
Other Study ID Numbers: P120905
2014-000393-19 ( EudraCT Number )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Blood brain barrier (BBB)
Disruption
Low intensity pulsed ultrasound (LIPU)
Sonocloud device
 Glioblastoma (GBM)
Brain Cancer
Carboplatin
Therapeutic Ultrasound
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carboplatin
Antineoplastic Agents