Health Trials

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

ConditionsGlioblastomaRecurrent GlioblastomaGBM
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarThera

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: Experimental Arm: SonoCloud-9 Ultrasound + CarboplatinExperimental treatment 2 interventions
Group B: Control Arm: SoC single agent chemotherapy TMZ or CCNUActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

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).

Time frame
Up to 24 months

Secondary outcomes

1

Tumor Growth Rate

Tumor Growth Rate will be determined by measuring hyperintense tumor volume using T1w contrast-enhancing tumor-related region from post-surgery MRI baseline to unequivocal progression MRI (i.e., suspected radiologic progression confirmed by repeat scan).

Time frame
Up to week 24
2

Progression Free Survival (PFS)

Defined as the time from date of randomization to the earlier of the following events: unequivocal tumor progression as determined by IRC per RANO criteria or death due to any cause.

Time frame
Up to 24 months
3

Overall survival at 12 months (OS12)

Defined as the proportion of participants alive at 12 months

Time frame
12 months
4

Overall survival at 18 months (OS18)

Defined as the proportion of participants alive at 18 months

Time frame
18 months

Other outcomes

1

Safety and Tolerability

Frequency and severity of adverse events scored according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, from surgery to End-of-Trial Intervention visit

Time frame
Up to week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CarThera

Lead sponsor

Source ClinicalTrials.gov
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