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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744026
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
CarThera

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Glioblastoma, Adult Device: SonoCloud-9 Drug: Carboplatin Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Carboplatin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744026


Contacts
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Contact: Carole DESSEAUX +33 (0)1 57 27 46 84 carole.desseaux@carthera.eu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Roger STUPP, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: John DE GROOT, MD         
France
CHU Recruiting
Angers, France
Contact: Philippe MENEI, MD         
Hôpital Neurologique Pierre Wertheimer Recruiting
Bron, France
Contact: François DUCRAY, MD         
Hôpital de La Timone Recruiting
Marseille, France
Contact: Olivier CHINOT, MD         
Hôpital de la Pitié-Salpêtrière Recruiting
Paris, France
Contact: Ahmed IDBAIH, MD         
Sub-Investigator: Alexandre CARPENTIER, MD         
Sponsors and Collaborators
CarThera
Investigators
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Principal Investigator: Ahmed IDBAIH, MD APHP
More Information
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Additional Information:

Publications:

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Responsible Party: CarThera
ClinicalTrials.gov Identifier: NCT03744026    
Other Study ID Numbers: SC9-GBM-01
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by CarThera:
Recurrent Glioblastoma
Carboplatin
Ultrasound
Blood-brain barrier
 Glioblastoma
SonoCloud
Low Intensity Pulsed Ultrasound (LIPU)
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carboplatin
Antineoplastic Agents