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

NCT ID: NCT05902169

Condition: Glioblastoma
Recurrent Glioblastoma
GBM

Conditions: Official terms:
Glioblastoma
Carboplatin
Temozolomide
Lomustine

Conditions: Keywords:
carboplatin
SonoCloud
blood-brain barrier
Low Intensity Pulsed Ultrasound (LIPU)

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: SonoCloud-9 (SC9)
Description: Implantation of SC9 device and repeat activation at constant acoustic pressure
Arm group label: Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin

Intervention type: Drug
Intervention name: Carboplatin
Description: 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].
Arm group label: Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin

Other name: CycloButane DiCarboxylic Acid (CBDCA)

Intervention type: Drug
Intervention name: Lomustine
Description: Dosed and administered per labelling.
Arm group label: Control Arm: SoC single agent chemotherapy TMZ or CCNU

Other name: 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU)

Intervention type: Drug
Intervention name: Temozolomide
Description: Dosed and administered per labelling.
Arm group label: Control Arm: SoC single agent chemotherapy TMZ or CCNU

Other name: Temodal

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry. 2. Patient must have received prior first line therapy that must have contained both: 1. 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) 2. One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields) 3. First, unequivocal disease progression with 1. 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, 2. 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 4. Patient is candidate for craniotomy and at least 50% resection of enhancing region 5. 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) 6. WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70) 7. Age ≥ 18 years 8. Participant must be recovered from acute toxic effects ( 90 mm Hg), uncontrolled systemic hypertension, or acute respiratory distress syndrome 18. Known sensitivity/allergy to gadolinium, or other intravascular contrast agents 19. Patient with impaired thermo-regulation or temperature sensation 20. Pregnant, or breastfeeding patient 21. Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care (e.g., positive human immunodeficiency virus [HIV] status, potential blood-borne infections,...), circumstance (e.g., sinus opening during surgery), psychological, morphological characteristics (e.g., skin characteristics, bone thickness), or any pre-existing comorbidities that in the investigator's opinion may prevent the implantation of the device, may impair the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical trial endpoints 22. Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision Exclusion Criterion: Occurrence of any major medical illnesses or impairments that in the Investigator's opinion may hampered the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical endpoints.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Miami Cancer Institute

Address:
City: Miami
Zip: 33176
Country: United States

Status: Recruiting

Contact:
Last name: Yazmin Odia, MD

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Status: Recruiting

Contact:
Last name: Rimas Lukas, MD

Facility:
Name: Indiana University Health

Address:
City: Indianapolis
Zip: 46202
Country: United States

Status: Recruiting

Contact:
Last name: Kathryn Nevel, MD

Facility:
Name: John Hopkins University

Address:
City: Baltimore
Zip: 21287
Country: United States

Status: Recruiting

Contact:
Last name: Chetan Bettegowda, MD

Facility:
Name: NewYork-Presbyterian / Columbia University Irving Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Brian JA Gill, MD

Facility:
Name: Lennox Hill Hospital

Address:
City: New York
Zip: 10075
Country: United States

Status: Recruiting

Contact:
Last name: Randy D'Amico, MD

Facility:
Name: University of North Carolina

Address:
City: Chapel Hill
Zip: 27516
Country: United States

Status: Recruiting

Contact:
Last name: Dominique Higgins, MD

Facility:
Name: University of Texas Houston Health Science Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Yoshua Esquenazi, MD

Facility:
Name: University of Utah, Hunstman Cancer Institute

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Status: Recruiting

Contact:
Last name: Randy Jenssen, MD

Facility:
Name: Universitair Ziekenhuis Brussel

Address:
City: Brussel
Country: Belgium

Status: Recruiting

Contact:
Last name: Duerinck Johnny, MD

Facility:
Name: Universitair Ziekenhuis Leuven

Address:
City: Leuven
Country: Belgium

Status: Recruiting

Contact:
Last name: Steven de Vleeschouwer, MD

Facility:
Name: CHU de Liège

Address:
City: Liège
Country: Belgium

Status: Recruiting

Contact:
Last name: Pierre Frères, MD

Facility:
Name: Hôpital Neurologique Pierre Wertheimer

Address:
City: Bron
Country: France

Status: Recruiting

Contact:
Last name: François Ducray, MD

Facility:
Name: Hôpital de La Timone

Address:
City: Marseille
Country: France

Status: Recruiting

Contact:
Last name: Olivier Chinot, MD

Facility:
Name: Hôpital de la Pitié-Salpêtrière

Address:
City: Paris
Country: France

Status: Recruiting

Contact:
Last name: Ahmed Idbaih, MD

Facility:
Name: Hôpital Foch

Address:
City: Suresnes
Zip: 92150
Country: France

Status: Recruiting

Contact:
Last name: Nadia Younan, MD

Facility:
Name: Klinikum Chemnitz gGmbH

Address:
City: Chemnitz
Zip: 09113
Country: Germany

Status: Recruiting

Contact:
Last name: Sven-Axel May, MD

Facility:
Name: Neurochirurgie uniklinik Köln

Address:
City: Köln
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Roland Goldbrunner, MD

Facility:
Name: Istituto Oncologico Veneto

Address:
City: Padua
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Giuseppe Lombardi, MD

Facility:
Name: Erasmus Medisch Centrum (Erasmus MC)

Address:
City: Rotterdam
Country: Netherlands

Status: Recruiting

Contact:
Last name: Martin van den Bent, MD

Facility:
Name: Vall d'Hebron Institute of Oncology (VHIO)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Contact:
Last name: Maria Vieito Villar, MD

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Country: Spain

Status: Recruiting

Contact:
Last name: Angel Perez-Nunez, MD

Facility:
Name: Inselspital Bern

Address:
City: Bern
Zip: 3010
Country: Switzerland

Status: Recruiting

Contact:
Last name: Philippe Schucht, MD

Facility:
Name: Centre Hospitalier Universitaire Vaudois (CHUV)

Address:
City: Lausanne
Zip: 1011
Country: Switzerland

Status: Recruiting

Contact:
Last name: Andreas Hottinger, MD

Start date: January 29, 2024

Completion date: June 30, 2028

Lead sponsor:
Agency: CarThera
Agency class: Industry

Source: CarThera

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05902169
http://www.carthera.eu

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