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Safety of BBB Opening With the SonoCloud (SONOCLOUD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02253212
First received: September 29, 2014
Last updated: September 14, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Glioblastoma
Glioma
Brain Tumor
Device: SonoCloud
Drug: Carboplatin
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: SonoCloud + carboplatin
SonoCloud : dose escalation Carboplatin : 6 cycles - individual dose determination according to renal function and AUC
Device: SonoCloud
SonoCloud : dose escalation
Drug: Carboplatin
Carboplatin : 6 cycles - individual dose determination according to renal function and AUC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02253212

Contacts
Contact: Alexandre C Carpentier, MD, PhD 001 33 142163430 alexandre.carpentier@psl.aphp.fr

Locations
France
Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department Recruiting
Paris, France, 75013
Contact: Alexandre C Carpentier, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ahmed Idbaih, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02253212     History of Changes
Other Study ID Numbers: P120905
Study First Received: September 29, 2014
Last Updated: September 14, 2016

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on March 22, 2017