General information
  • Disease category Head and Neck Cancer , Nervous System diseases (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Bern, Lausanne
    (BASEC)
  • Contact Adjunct Professor Andreas Felix Hottinger andreas.hottinger@chuv.ch (BASEC)
  • Data Source(s) BASEC: Import from 23.04.2025 ICTRP: N/A
  • Last update 23.04.2025 16:25
HumRes65196 | SNCTP000005975 | BASEC2023-D0119

A randomized, unblinded, multicenter, two-arm registration study of SonoCloud-9 combined with Carboplatin (CBDCA) compared to standard Lomustine (CCNU) or Temozolomide (TMZ) in patients undergoing planned resection for a first recurrent glioblastoma - SONOBIRD

  • Disease category Head and Neck Cancer , Nervous System diseases (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Bern, Lausanne
    (BASEC)
  • Contact Adjunct Professor Andreas Felix Hottinger andreas.hottinger@chuv.ch (BASEC)
  • Data Source(s) BASEC: Import from 23.04.2025 ICTRP: N/A
  • Last update 23.04.2025 16:25

Summary description of the study

The brain is protected by the blood-brain barrier from the entry of toxic (poisonous) or inflammatory molecules. This physical barrier is located at the level of the blood vessel walls. Due to these barrier properties of blood vessels, no therapeutic molecules can pass from the blood to the brain. The development of effective treatments against glioblastomas is therefore limited, as the blood-brain barrier prevents most drugs from passing from the bloodstream to the brain tissue, where the tumor is located. SonoCloud-9 (SC9) is an investigational product that uses ultrasound technology and is specifically designed to open the blood-brain barrier in the area and around the tumor. The temporary opening of the blood-brain barrier allows more drugs to reach the tumor tissue in the brain. Carboplatin is a chemotherapy approved alone or in combination with other drugs for the treatment of various cancers. Carboplatin is also used in the treatment of glioblastomas. Although it is shown to act against glioblastoma cells in the lab, it does not sufficiently cross the blood-brain barrier in humans. A clinical study has shown that in combination with SonoCloud-9, more Carboplatin reaches the tumor tissue in the brain. The aim of the planned study is to demonstrate that the combination of Carboplatin with SonoCloud-9 increases the efficacy of the drug in patients with recurrent glioblastoma.

(BASEC)

Intervention under investigation

SonoCloud-9 mediated opening of the blood-brain barrier to improve the efficacy of Carboplatin.

(BASEC)

Disease under investigation

Recurrent glioblastoma (a specific type of brain tumor)

(BASEC)

Criteria for participation in trial
1. Histologically proven glioblastoma (WHO CRITERIA 2021), absence of an IDH mutation proven by negative IDH1-R132H staining in the context of an IHC procedure. 2. The patient must have previously received a first-line therapy that must have included the following two components: a) Surgery or biopsy and a standard fractionated radiotherapy (1.8 to 2 Gy/fraction, > 56 Gy, < 66 Gy) or a hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen) b) A maintenance chemotherapy line and/or an immunotherapy or biologic therapy (with or without TTFields) 3. There must have been a first unequivocal disease progression, with a) measurable tumor (>100 mm2 or 1 cm3, according to RANO criteria), documented (e.g., increase in tumor diameter by 25%) on MRI performed within 14 days prior to study enrollment, and b) the last radiotherapy must have been completed at least 12 weeks prior, unless there is a new lesion outside the radiation field or clear evidence of a viable tumor in the form of a histopathological sample. (BASEC)

Exclusion criteria
1. T1-weighting shows multifocal enhanced tumor areas (unless all are located within a 5 cm diameter area) 2. Tumor of the posterior cranial fossa 3. The patient has a known BRAF/NTKR mutation (BASEC)

Trial sites

Bern, Lausanne

(BASEC)

not available

Sponsor

Dr. Gaëlle Preiss Voisin Consulting CH Sarl EPFL – Innovation Park, Bâtiment F 1015 Lausanne preiss-legalrep@voisinconsulting.com +41 21 547 04 43

(BASEC)

Contact

Contact Person Switzerland

Adjunct Professor Andreas Felix Hottinger

+41795565271

andreas.hottinger@chuv.ch

Centre Hospitalier Universitaire Vaudois (CHUV), Department of Clinical Neurosciences

(BASEC)

Scientific Information

not available

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Vaud

(BASEC)

Date of authorisation

04.07.2024

(BASEC)


ICTRP Trial ID
not available

Official title (approved by ethics committee)
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma (BASEC)

Academic title
not available

Public title
not available

Disease under investigation
not available

Intervention under investigation
not available

Type of trial
not available

Trial design
not available

Inclusion/Exclusion criteria
not available

not available

Primary and secondary end points
not available

not available

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
not available

Secondary trial IDs
not available

Results-Individual Participant Data (IPD)
not available

Further information on the trial
not available


Results of the trial

Results summary

not available

Link to the results in the primary register

not available