System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting Phase 3

NCT05902169 on ClinicalTrials.gov

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

Official title: 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.

  • Sponsor: CarThera
  • Enrollment: 560 (Estimated)
  • Study start: 2024-01-29 (Actual)
  • Primary completion: 2028-01-28 (Estimated)
  • Study completion: 2028-06-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Glioblastoma
  • Recurrent Glioblastoma
  • GBM

Intervention / Treatment

  • Device: SonoCloud-9 (SC9)
  • Drug: Carboplatin
  • Drug: Lomustine
  • Drug: Temozolomide

Primary Outcome Measures

  • Overall survival (OS) (Up to 24 months)
    Survival status will be collected during the treatment period, for up to 7 months (short-term follow-up) and then every 3 months as standard of care follow-up (long-term follow-up) until participant's 'End of Study', defined as end of survival follow-up period, death, withdrawal of consent for the collection of data, or 'lost to follow-up' (whichever comes first).

Countries

Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United States

Locations and Investigators

  • Uppsala University Hospital, Uppsala, Sweden
    • Georg, Holgersson
  • Sahlgrenska University Hospital-Vaestra Goetalandsregionen, Goteborg, Sweden
    • Louise, Carstam
  • Haaglanden Medisch Centrum Stichting, 'S-Gravenhage, Netherlands
    • Marike Lianne Daphne, Broekman
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam, Netherlands
    • Marjolein, Geurts
  • Hospital Universitario Hm Sanchinarro, Madrid, Spain
    • Juan Manuel, Sepúlveda Sánchez
  • University Hospital Virgen Del Rocio S.L., Sevilla, Spain
    • José Luis, Narros Giménez
  • Hospital Universitari Vall D Hebron, Barcelona, Spain
    • Maria, Vieito Villar
  • Hospital Clinic De Barcelona, Barcelona, Spain
    • Jose Juan, Gonzalez Sánchez
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Angel, Pérez Núñez
  • I.F.O. Istituti Fisioterapici Ospitalieri, Rome, Italy
    • Veronica, Villani
  • Humanitas Research Hospital, Rozzano, Italy
    • Matteo, Simonelli
  • Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino, Turin, Italy
    • Roberta, Rudà
  • Istituto Oncologico Veneto, Padova, Italy
  • Azienda Unita Sanitaria Locale Di Bologna, Bologna, Italy
    • Enrico, Franceschi
  • Azienda Unita Sanitaria Locale Toscana Nord Ovest, Leghorn, Italy
    • Anna Luisa, Di Stefano
  • Medizinische Universitaet Innsbruck, Innsbruck, Austria
    • Christian, Freyschlag
  • UZ Leuven, Leuven, Belgium
    • Steven, De Vleeschouwer
  • CHU De Liege, Liege, Belgium
    • Pierre, Freres
  • UZ Brussel, Jette, Belgium
    • Johnny, Duerinck
  • Hospital Foch, Suresnes, France
    • Nadia, Younan
  • Assistance Publique Hopitaux De Marseille, Marseille, France
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Hospices Civils De Lyon, Bron, France
    • François, Ducray
  • Klinikum Chemnitz gGmbH, Chemnitz, Germany
    • Sven-Axel, May
  • Charite Universitaetsmedizin Berlin KöR, Berlin, Germany
    • Martin, Misch
  • Universitaetsklinikum Essen AöR, Essen, Germany
    • Sied, Kebir
  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR, Dresden, Germany
    • Dietmar, Krex
  • University Medical Center Hamburg-Eppendorf, Hamburg, Germany
    • Hanno S., Meyer
  • University Hospital Cologne AöR, Cologne, Germany
    • Roland, Goldbrunner
  • Universitaetsklinikum Muenster AöR, Muenster, Germany
    • Walter, Stummer
  • Rigshospitalet, Copenhagen Oe, Denmark
    • Jane, Skjøth-Rasmussen
  • Odense University Hospital, Odense C, Denmark
    • Frantz Rom, Poulsen