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
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)
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)
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@clutterchuv.chCentre 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
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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