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Safety of BBB Opening With the SonoCloud

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02253212
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ahmed Idbaih, MD, PhD
Principal Investigator Affiliation Assistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Glioma, Brain Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: SonoCloud + carboplatin

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

Interventions

Device: - SonoCloud

SonoCloud : dose escalation

Drug: - Carboplatin

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Paris, France

Status

Address

Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department

Paris, , 75013

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