Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin. Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• patient aged ≥ 5 years old and \< 18 years old

• patient able to receive sonications and perform MRI studies without sedation

• diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma)

• recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed)

• indication of treatment with carboplatin, validated in multidisciplinary meeting

• Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients \< 16 years old) \> 50% (a patient with a performance status score altered by a motor deficit due to tumor infiltration will be allowed to be included)

• no threat of brain herniation or uncontrolled intracranial hypertension

• corticosteroids treatment ≤ 1mg/kg/day

• neutrophils \> 1.5 x 109/L

• platelets \> 100 x 109/L

• total bilirubin \< 1.5x upper limit of normal, AST et ALT \< 2.5x upper limit of normal

• serum creatinin \< 1.5x upper limit of normal for the age or creatinine clairance \>70mL/min/1.73m2 (EDTA method or 24h urine)

• coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)

• no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria

• no healed wound on the scalp

• covered by health insurance

• for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control

• written consent signed by the patient (if possible) and his parents or legal representatives.

Locations
Other Locations
France
Institut Curie
RECRUITING
Paris
Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades
RECRUITING
Paris
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Kevin BECCARIA, MD, PhD
kevin.beccaria@aphp.fr
+33 1 71 39 65 92
Backup
Nelly BRIAND, MD, PhD
nelly.briand@aphp.fr
+33 1 44 38 18 62
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2027-10
Participants
Target number of participants: 24
Treatments
Experimental: SonoCloud®
SonoCloud® : dose escalation 6 cycles of sonication
Related Therapeutic Areas
Sponsors
Collaborators: Institut Curie, Gustave Roussy, Cancer Campus, Grand Paris, CarThera
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov