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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
CarThera
Study ID
NCT05902169
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SonoCloud-9 (SC9) — DEVICE
    Implantation of SC9 device and repeat activation at constant acoustic pressure
  • Carboplatin — DRUG
    Dose of carboplatin AUC 5 mg/ml.min-1 calculated using Calvert's formula: Dose (mg) = target AUC (mg/mL x minute) x \[glomerular filtration rate (GFR) mL/minute + 25\].
  • Lomustine — DRUG
    Dosed and administered per labelling.
  • Temozolomide — DRUG
    Dosed and administered per labelling.

Study Details

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 Dates

First listed
Jun 13, 2023
Start date
Jan 29, 2024
Status verified
Aug 2026
Primary completion
Jan 28, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
560 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona805054-
Kaiser PermanenteLos AngelesCalifornia90027
Daniel Green, MD
UCLALos AngelesCalifornia90095
Richard Everson, MD
Sutter Health - California Pacific Medical CenterSan FranciscoCalifornia94109
Lewis Leng, MD
University of California, San FranciscoSan FranciscoCalifornia94143-
UCHealthAuroraColorado80011
Kevin Lillehei, MD
Mayo Clinic of Jacksonville FloridaJacksonvilleFlorida32224-
Miami Cancer InstituteMiamiFlorida33176
Michael Mc Dermott, MD
Moffitt Cancer CenterTampaFlorida33612
James Liu, MD
Winship Cancer Institute at Emory UniversityAtlantaGeorgia30322
Edjah Nduom, MD
Northwestern UniversityChicagoIllinois60611
Rimas Lukas, MD
Indiana University HealthIndianapolisIndiana46202
Kathryn Nevel, MD
John Hopkins UniversityBaltimoreMaryland21287-
Mayo Clinic RochesterRochesterMinnesota55905-
Lennox Hill HospitalNew YorkNew York10075
Randy D'Amico, MD
NewYork-Presbyterian / Columbia University Irving Medical CenterNew YorkNew York10032
Brian JA Gill, MD
[email protected]
212-342-5162
Weill Cornell MedicineNew YorkNew York10021
Rohan Ramakhrisna, MD
University of North CarolinaChapel HillNorth Carolina27516
Carlos David, MD
Neurological Institute Brain Tumor Centre Taussig Cancer CenteClevelandOhio44106
Matthew Grabowski, MD
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033-
University of Texas Southwestern Medical CenterDallasTexas75390
Toral Patel, MD
University of Texas Houston Health Science CenterHoustonTexas77030-
University of Utah, Hunstman Cancer InstituteSalt Lake CityUtah84112
Randy Jenssen, MD

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