Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9 (SC9-GBM-01)

September 6, 2022 updated by: CarThera

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU
      • Bron, France
        • Hopital Neurologique Pierre Wertheimer
      • Marseille, France
        • Hopital de la Timone
      • Paris, France
        • Hôpital de la Pitié-Salpêtrière
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Age ≥ 18 years, able and willing to give signed and informed consent.

  2. Patient with histologically proven recurrent de novo GBM:

    1. After at least a first-line standard of care (maximal safe resection, if feasible, radiation with temozolomide [TMZ], then TMZ);
    2. Any recurrence;
    3. Bevacizumab-naïve.*
  3. Patient eligible for carboplatin-based chemotherapy.
  4. Patient eligible for a surgical resection.
  5. Maximal tumor diameter at inclusion (pre surgery) ≤ 70 mm in T1wMRI.
  6. Patients should be stable, without evidence of a midline shift, significant peritumoral edema, or rapid progression of clinical symptoms.
  7. Karnofsky performance status ≥ 70.
  8. Patient receiving prednisone dose ≤ 40 mg (dexamethasone ≤ 6 mg) for at least 7 days.

Key Exclusion Criteria:

  1. Multifocal tumor (unless all localized in a 70 mm diameter area).
  2. 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).
  3. Posterior fossa tumor.
  4. Uncontrolled epilepsy.
  5. Patients with evidence of uncontrolled intracranial pressure.
  6. Patients with known intracranial aneurism or having presented intra-tumor spontaneous hemorrhage.
  7. Patients with coils, clips, shunts, intravascular stents, and/or unremovable wafer, non resorbable dura substitute, or reservoirs.
  8. Patients with medical need to continue antiplatelet therapy.
  9. Patients with known or suspected active or chronic infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SonoCloud-9 Ultrasound + Carboplatin
SonoCloud-9 Carboplatin: 6 cycles (every 4 weeks)
Device: SonoCloud-9
Escalating numbers of ultrasound beams at constant acoustic pressure
Drug: Carboplatin
Dose of carboplatin infusion is AUC4-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity (DLT) of number of activated ultrasound beams
Time Frame: 15 days after the first sonication treatment
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.
15 days after the first sonication treatment
Blood-Brain Barrier (BBB) opening
Time Frame: At the end of the first three sonication treatments (treatment occurs every 4 weeks)
BBB opening will be evaluated by contrast-enhanced T1w magnetic resonance imaging (MRI)
At the end of the first three sonication treatments (treatment occurs every 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CarThera

Investigators

  • Principal Investigator: Ahmed IDBAIH, MD, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2019

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC9-GBM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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