Safety of BBB Opening With the SonoCloud (SONOCLOUD)
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| ClinicalTrials.gov Identifier: NCT02253212 |
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Recruitment Status :
Completed
First Posted : October 1, 2014
Last Update Posted : October 12, 2018
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PURPOSE: The purpose of this study is to determine whether transient opening of the blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery of carboplatin-based chemotherapy.
STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to carboplatin-based chemotherapy and increase progression-free and overall survival in patients with recurrent glioblastoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma Glioma Brain Tumor | Device: SonoCloud Drug: Carboplatin | Phase 1 Phase 2 |
For patients with recurrent malignant gliomas, who have already been treated by a combination of surgery, radiation therapy and/or chemotherapy, few treatment options currently exist. Salvage therapies typically consist of systemic administration of chemotherapy agents, which have been shown to have limited effectiveness as median survival in this patient group is currently only 6 months.
One limitation to the efficacy of systemic chemotherapy in the treatment of brain tumors is the blood-brain barrier (BBB). To enhance the delivery of systemically administered chemotherapy agents to brain tumors, an implantable ultrasound device was developed that can be used to temporarily disrupt the BBB. Delivery of pulsed ultrasound, in combination with an ultrasound contrast agent, has been shown to temporarily disrupt the BBB for a duration of more than 6 hours and allow for a significantly increased penetration of systemically administered chemotherapy drugs in pre-clinical studies.
This study will evaluate the safety of temporary disruption of the BBB during carboplatin chemotherapy delivery in patients with recurrent glioblastoma. This study will also evaluate the maximum tolerated dose of ultrasound that can be used to disrupt the BBB.
The use of dynamic contrast-enhanced MRI will be evaluated for determining the extent and magnitude of BBB opening. Clinical efficacy (Survival) and radiological efficacy (Progression Free Survival) will also be evaluated as secondary endpoints.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Study to Evaluate the Safety of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SonoCloud Implantable Device in Patients With Recurrent Glioblastoma Before Chemotherapy Administration |
| Actual Study Start Date : | July 2014 |
| Actual Primary Completion Date : | July 2018 |
| Actual Study Completion Date : | July 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SonoCloud + carboplatin
SonoCloud : dose escalation Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC
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Device: SonoCloud
SonoCloud : dose escalation Drug: Carboplatin Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC |
- Safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma. [ Time Frame: 12 months ]
- Maximum tolerated dose of ultrasound with the SonoCloud system for transient disruption of the BBB. [ Time Frame: 12 months ]
- Quantification of the disruption of the BBB by the SonoCloud system using dynamic T1 contrast-enhanced MRI. [ Time Frame: 12 months ]
- Progression-free survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
- Overall survival in patients treated with the SonoCloud system in combination with carboplatin chemotherapy. [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Age greater than 18 years.
- Subjects with recurrent glioma who have failed standard therapy with surgery and/or treatment with radiation and temozolomide.
- Patient eligible for Carboplatin-based chemotherapy
- Contrast-enhanced tumor less than 35 mm in diameter
- No risk of cerebral herniation
- Able to tolerate pre/post procedure steroid treatment
- Social security affiliated (in France)
- Able and willing to give signed and informed consent
- Normal biological status
- Hemoglobin ≥ 10 g/dl
- Platelets ≥ 100000/mm3
- Neutrophils ≥ 1500/mm3
- Normal creatine clearance ≥ 60ml/mn
- ASAT < 3 N
- ALAT < 3 N
- Normal Bilirubin Level < 1.5 N
- Alkaline Phosphatase < 3 N
- INR < 1.5
- Prothrombin Level ≥ 70%
Exclusion criteria:
- Allergic to Iodine, Gadolinium, Xylocain
- Contra-indications to echographic contrast agent (microbubbles)
- Severe Renal insufficiency
- Hepatic insufficiency
- Possible toxic treatment for CNS
- Previously infected surgical field
- Uncontrolled epilepsy
- MRI contra-indications
- Hemostasis troubles thrombopenia <75.000, TP <60%, INR >1.5, anti-platelet or anticoagulant therapy on-going)
- Active phlebitis or active pulmonary embolism
- Pregnant or currently breast-feeding
- Patients under judicial protection
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): NCT02253212
| France | |
| Groupe Hospitalier Pitié Salpetriere - Neurosurgery Department | |
| Paris, France, 75013 | |
| Principal Investigator: | Ahmed Idbaih, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT02253212 History of Changes |
| Other Study ID Numbers: |
P120905 2014-000393-19 ( EudraCT Number ) |
| First Posted: | October 1, 2014 Key Record Dates |
| Last Update Posted: | October 12, 2018 |
| Last Verified: | October 2018 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Blood brain barrier (BBB) Disruption Low intensity pulsed ultrasound (LIPU) Sonocloud device |
Glioblastoma (GBM) Brain Cancer Carboplatin Therapeutic Ultrasound |
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 |