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.

Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 performed within 14 days of inclusion 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 candidate for craniotomy and at least 50% resection of enhancing region

• Maximal enhancing tumor diameter prior to inclusion ≤ 5 cm on T1w. (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 of 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/1.73 m2 using Cockcroft Gault formula

⁃ 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 of 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.

⁃ Patient must be a beneficiary of a health plan that covers routine patient care costs. Patient must be a beneficiary of or affiliated with a social security scheme (according to country-specific requirements)

Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
California
University of California, San Francisco
RECRUITING
San Francisco
Colorado
UCHealth
RECRUITING
Aurora
Florida
Mayo Clinic of Jacksonville Florida
RECRUITING
Jacksonville
Miami Cancer Institute
RECRUITING
Miami
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Winship Cancer Institute at Emory University
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Indiana
Indiana University Health
RECRUITING
Indianapolis
Maryland
John Hopkins University
RECRUITING
Baltimore
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
Lennox Hill Hospital
RECRUITING
New York
NewYork-Presbyterian / Columbia University Irving Medical Center
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
University of Texas Houston Health Science Center
RECRUITING
Houston
Utah
University of Utah, Hunstman Cancer Institute
RECRUITING
Salt Lake City
Other Locations
Austria
Medizinische Universitaet Innsbruck
RECRUITING
Innsbruck
Belgium
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
CHU de Liège
RECRUITING
Liège
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
France
Hôpital Neurologique Pierre Wertheimer
RECRUITING
Bron
Hôpital de La Timone
RECRUITING
Marseille
Hôpital de la Pitié-Salpêtrière
RECRUITING
Paris
Hôpital Foch
RECRUITING
Suresnes
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Klinikum Chemnitz gGmbH
RECRUITING
Chemnitz
Neurochirurgie uniklinik Köln
RECRUITING
Cologne
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitätsklinikum Essen Klinik für Neurologie
RECRUITING
Essen
Italy
Ospedale Bellaria
RECRUITING
Bologna
Ospedale Civile di Livorno
RECRUITING
Livorno
Istituto Oncologico Veneto
RECRUITING
Padua
Irccs Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
RECRUITING
Torino
Netherlands
Erasmus Medisch Centrum (Erasmus MC)
RECRUITING
Rotterdam
Haaglanden Medisch Centrum
RECRUITING
The Hague
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Vall d'Hebron Institute of Oncology (VHIO)
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Switzerland
Inselspital Bern
RECRUITING
Bern
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Carole Desseaux
contact@carthera.eu
+33 472 626 268
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 560
Treatments
Experimental: Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin
The SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.
Active_comparator: Control Arm: SoC single agent chemotherapy TMZ or CCNU
Standard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU).~Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles.~Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.
Sponsors
Leads: CarThera

This content was sourced from clinicaltrials.gov

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