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Glioblastoma, AdultPhase 1/2SC9-GBM-01NCT03744026

Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9

A Phase 1/2 study testing SonoCloud-9 and Carboplatin in people with Glioblastoma, Adult, run by CarThera at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recurrent glioblastoma (GBM) is a disease with high unmet clinical need. The standard of care for patients with GBM includes surgery, radiotherapy and chemotherapy. Despite this aggressive treatment, the overall median survival of patients with GBM remains at 15-20 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Adult
What is being tested?
SonoCloud-9 and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
6 sitesin 2 countries
Study dates
18 Feb 2019to 30 Jun 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, able and willing to give signed and informed consent.
  • Patient with histologically proven recurrent de novo GBM:
  • After at least a first-line standard of care (maximal safe resection, if feasible, radiation with temozolomide [TMZ], then TMZ);
  • Any recurrence;
  • Bevacizumab-naïve.*
  • Patient eligible for carboplatin-based chemotherapy.
Show all 11Show fewer
  • Patient eligible for a surgical resection.
  • Maximal tumor diameter at inclusion (pre surgery) ≤ 70 mm in T1wMRI.
  • Patients should be stable, without evidence of a midline shift, significant peritumoral edema, or rapid progression of clinical symptoms.
  • Karnofsky performance status ≥ 70.
  • Patient receiving prednisone dose ≤ 40 mg (dexamethasone ≤ 6 mg) for at least 7 days.

Who cannot join

  • Multifocal tumor (unless all localized in a 70 mm diameter area).
  • Patients at risk of surgery site infection (2 or more previous craniotomies, neurosurgery within the last 3 months, poor skin condition, and/or previously infected surgical field).
  • Posterior fossa tumor.
  • Uncontrolled epilepsy.
  • Patients with evidence of uncontrolled intracranial pressure.
  • Patients with known intracranial aneurism or having presented intra-tumor spontaneous hemorrhage.
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  • Patients with coils, clips, shunts, intravascular stents, and/or unremovable wafer, non resorbable dura substitute, or reservoirs.
  • Patients with medical need to continue antiplatelet therapy.
  • Patients with known or suspected active or chronic infections.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

France4 sites

  • CHU

    Angers

  • Hôpital Neurologique Pierre Wertheimer

    Bron

  • Hôpital de La Timone

    Marseille

  • Hôpital de la Pitié-Salpêtrière

    Paris

Other trials in France

United States2 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier (BBB) by Low Intensity Pulsed Ultrasound With the SonoCloud-9 Implantable Device in Recurrent Glioblastoma Patients Eligible for Surgery and for Carboplatin Chemotherapy

Recurrent glioblastoma (GBM) is a disease with high unmet clinical need. The standard of care for patients with GBM includes surgery, radiotherapy and chemotherapy. Despite this aggressive treatment, the overall median survival of patients with GBM remains at 15-20 months.

In more than 95% of cases, tumor recurrence is observed within 2 cm to 3 cm of the resection cavity within 4-7 months after initial treatments. One of the main causes of recurrence is the inability of chemotherapies to enter the brain from the systemic circulation due to the blood-brain barrier (BBB). The BBB is unique to cerebral blood vessels and blocks most drugs from entering the brain in sufficient concentrations.

The SonoCloud-9 (SC9) System delivers ultrasound to locally and transiently increase the permeability of the BBB to allow the passage of drugs into the cerebral parenchyma. The SC9 is dimensioned to cover the resection area and surrounding tissues in patients with recurrent GBM. The large sonicated volume covered by the SC9 device allows for broad BBB disruption and should allow for carboplatin chemotherapy to penetrate the surrounding tumor infiltrative area. By enhancing drug concentrations, it is hypothesized that further disease progression will be prevented.

Read the detailed description

This will be an open-label, Phase 1/2a, multicenter, single-arm, interventional trial that will first evaluate the dose limiting toxicity (DLT) of escalating numbers of ultrasound beams at constant acoustic pressure using a standard escalation (Phase 1) and then confirm the safety and efficacy of BBB opening (Phase 2a expansion).

Being tested
SonoCloud-9, Carboplatin
Keywords
Recurrent Glioblastoma, Carboplatin, Ultrasound, Blood-brain barrier, Glioblastoma, SonoCloud, Low Intensity Pulsed Ultrasound (LIPU)
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SonoCloud-9Device

    Escalating numbers of ultrasound beams at constant acoustic pressure

  • CarboplatinDrug

    Dose of carboplatin infusion is AUC4-6

Study groups in NCT03744026
Study groupRoleWhat they receive
SonoCloud-9 Ultrasound + CarboplatinExperimentalSonoCloud-9 Carboplatin: 6 cycles (every 4 weeks)
Receives: Device: SonoCloud-9; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT) of number of activated ultrasound beams

    DLT will be evaluated using imaging (MRI) and clinical examination, as CTCAE that occurs within 2 weeks of the first sonication and that does not respond to optimal medical management (including steroids) within 7 days.

    Measured: 15 days after the first sonication treatment

  2. Blood-Brain Barrier (BBB) opening

    BBB opening will be evaluated by contrast-enhanced T1w magnetic resonance imaging (MRI)

    Measured: At the end of the first three sonication treatments (treatment occurs every 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2018
  2. Study start18 Feb 2019
  3. Primary completion23 Jun 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03744026
Sponsor's protocol ID
SC9-GBM-01
Acronym
SC9-GBM-01
Status last verified
Sep 2022
First submitted
13 Nov 2018
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

    PubMed 27306666

  • Carpentier A, Stupp R, Sonabend AM, Dufour H, Chinot O, Mathon B, Ducray F, Guyotat J, Baize N, Menei P, de Groot J, Weinberg JS, Liu BP, Guemas E, Desseaux C, Schmitt C, Bouchoux G, Canney M, Idbaih A. Repeated blood-brain barrier opening with a nine-emitter implantable ultrasound device in combination with carboplatin in recurrent glioblastoma: a phase I/II clinical trial. Nat Commun. 2024 Feb 23;15(1):1650. doi: 10.1038/s41467-024-45818-7.

    PubMed 38396134

  • Sonabend AM, Gould A, Amidei C, Ward R, Schmidt KA, Zhang DY, Gomez C, Bebawy JF, Liu BP, Bouchoux G, Desseaux C, Helenowski IB, Lukas RV, Dixit K, Kumthekar P, Arrieta VA, Lesniak MS, Carpentier A, Zhang H, Muzzio M, Canney M, Stupp R. Repeated blood-brain barrier opening with an implantable ultrasound device for delivery of albumin-bound paclitaxel in patients with recurrent glioblastoma: a phase 1 trial. Lancet Oncol. 2023 May;24(5):509-522. doi: 10.1016/S1470-2045(23)00112-2.

    PubMed 37142373

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SonoCloud-9 and Carboplatin in people with Glioblastoma, Adult, run by CarThera at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) of number of activated ultrasound beams (time frame: 15 days after the first sonication treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03744026, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.

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