Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

Recruiting now · Phase 3

Conditions studied: Glioblastoma, Recurrent Glioblastoma, GBM

In brief

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

Key facts

Study ID

NCT05902169

Run by

CarThera

People needed

560

Starts

2024-01-29

Expected to finish

2028-06-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.
• Patient must have received prior first line therapy that must have contained both:
• Prior surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy/fraction, ≥56 Gy<66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen)
• One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields)
• First, unequivocal disease progression with
• measurable tumor (>100 mm2 or 1 cm3, based on RANO criteria) documented (e.g., increase of 25% in tumor diameter) on MRI and,
• interval of a minimum of 12 weeks since the completion of prior radiotherapy, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling
• Patient is a candidate for craniotomy and at least 50% resection of enhancing region
• Maximal enhancing tumor diameter prior to inclusion ≤ 5 (+7%) cm on T1w on MRI performed within 14 days prior to inclusion§. (In case of planned lobectomy, post operative peritumoral brain or residual size ≤5 cm)
• WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70)
• Age ≥ 18 years
• Participant must be recovered from acute toxic effects (≤ grade 2) of all prior anticancer therapy. Interval since last therapy to presumed date of surgery of at least:
• ≥ 4 weeks or 5 half-lives (whichever is shorter) for
• Cytotoxic
• Other small chemical entity (e.g., targeted therapy)
• For biologics (e.g., antibodies, except bevacizumab)
• ≥ 6 weeks of prior bevacizumab
• Adequate hematologic, hepatic, and renal laboratory values within 14 days prior to inclusion§ i.e.:
• Hemoglobin ≥ 10 g/dL, platelets ≥ 100,000/mm3, neutrophils ≥ 1500/mm3.
• Liver function test with ≤ grade 1 alterations, except if due to antiepileptic drug therapy or isolated increased bilirubin due to Gilbert syndrome
• Estimated glomerular filtration rate (eGFR) of at least 60 mL/min/m2 using Appendix 12.4 formula
• AST(SGOT)/ALT(SPGT) ≤ 3 X institutional ULN (upper Limit of Normal)
• Patient able to understand clinical trial information and willing to provide signed and informed consent
• Patient of childbearing potential must have a negative pregnancy test within 14 days prior to inclusion§ and must agree to use a medically-acceptable method of birth control during the treatment period and, if randomized in the experimental arm, for at least 1 month after the last cycle of carboplatin
• A male patient must agree to use condoms during the treatment period and, if randomized in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from donating sperm during this period.

Where it is running

• Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Klinikum Chemnitz gGmbH — Chemnitz, Germany (enrolling)
• Hôpital de La Timone — Marseille, France (enrolling)
• Hôpital Foch — Suresnes, France (enrolling)
• UCHealth — Aurora, Colorado, United States (enrolling)
• Winship Cancer Institute at Emory University — Atlanta, Georgia, United States (enrolling)
• Odense University Hospital — Odense, Denmark (enrolling)
• Hôpital Neurologique Pierre Wertheimer — Bron, France (enrolling)
• Miami Cancer Institute — Miami, Florida, United States (enrolling)
• Hôpital de la Pitié-Salpêtrière — Paris, France (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• NewYork-Presbyterian / Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Lennox Hill Hospital — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Neurological Institute Brain Tumor Centre Taussig Cancer Cente — Cleveland, Ohio, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• University of Utah, Hunstman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• Medizinische Universitaet Innsbruck — Innsbruck, Austria (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Leuven — Leuven, Belgium (enrolling)
• CHU de Liège — Liège, Belgium (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• Neurochirurgie uniklinik Köln — Cologne, Germany (enrolling)

Full record on ClinicalTrials.gov

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