Informations générales (source: ClinicalTrials.gov)

NCT05293197 En recrutement IDF
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 (SONOKID)
Interventional
  • Tumeurs du cerveau
  • Gliome
  • Tumeurs
Phase 1
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2023
octobre 2026
29 juin 2024
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Necker-Enfants Malades BECCARIA Kevin En recrutement IDF 02/12/2024 12:47:56  Contacter
CLCC INSTITUT CURIE En recrutement IDF 04/12/2024 12:44:14  Contacter
CLCC INSTITUT GUSTAVE ROUSSY Jacques GRILL En recrutement IDF 29/03/2024 09:25:42  Contacter

Critères

Tous
Inclusion Criteria:

- 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.


- weight <15kg

- significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion

- antineoplastic treatment other than carboplatin taken at the same time or stopped
since less than:

- 6 weeks for nitrosoureas

- 1 month for temozolomide

- 1 month for bevacizumab

- 5 half-lives for tyrosin kinase inhibitors

- 3 weeks for any other chemotherapy

for the first sonication session

- radiotherapy during the last 6 weeks

- any other cancer treated during the last 5 years

- any other uncontrolled disease or active infection

- any other co-morbidity that could compromise participation to the study (in the
judgement of the clinical investigator)

- any anatomical particularity (skull thickness, thin skin) that could compromise a
safe implantation of the device and/or compromise the quality of the treatment (in
the judgement of the clinical investigator)

- implanted defibrillator/pacemaker, neurostimulator, cochlear implant, intracerebral
ferromagnetic vascular clip

- any contraindication to general anesthesia

- any contraindication to MRI or known allergy to gadolinium or other MRI contrast
agent/

- any contraindication to ultrasound contrast agent:

- allergy to the active substance or any excipient

- acute coronary syndrome or uncontrolled ischemic heart disease

- chronic heart failure or history of acute heart failure or heart failure grade
III or IV

- treatment with dobutamine

- severe pulmonary arterial hypertension

- uncontrolled systemic hypertension

- respiratory distress syndrome

- carboplartin hypersensitivity

- treatment with phenytoin or fosphenytoin

- earlier vaccination with attenuated alive vaccine

- diminished auditory acuity ≥ grade 3 on CTCAE classification

- history of thermoregulation disorder

- impossibility of a rigorous medical follow-up due to geographic, social or mental
reasons

- pregnant and lactating women

- contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs

- contemporaneous treatment possibly toxic for the central nervous system. The
following treatments are excluded if taken less than 5 half-lives before the
ultrasound session (unknown toxicity in case of BBB disruption) :

- benzodiazepine (or any sedative or hypnotique drug)

- antihistamine

- proconvulsant drugs

- butyrophenone, phenothiazine, or any "conventional" antipsychotic drug

- barbiturate

- MAO inhibitor

- anticholinergic

- anticoagulant

- any contemporaneous treatment that, in the judgement of the clinical investigator,
could induce brain toxicity after BBB disruption