Clinical Trials /

Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM

NCT04440358

Description:

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
  • Official Title: Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

Clinical Trial IDs

  • ORG STUDY ID: BT009 [OUS]
  • NCT ID: NCT04440358

Conditions

  • Recurrent Glioblastoma

Interventions

DrugSynonymsArms
CarboplatinExablate BBBD with carboplatin

Purpose

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

Detailed Description

      This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the
      safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous
      carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system.
      Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered
      for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD
      procedures in conjunction with carboplatin chemotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
Exablate BBBD with carboplatinExperimentalCarboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to carboplatin administration.
  • Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Must be between 18-80 years old

          -  Histologically confirmed glioblastoma

          -  Planned for Carboplatin monotherapy

          -  Be willing and able to provided written informed consent/assent

          -  Tumor progression after first line therapy

          -  Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic
             effects of prior therapy

          -  Women of childbearing potential is confirmed not pregnant. Male and Female subjects
             utilize highly effective contraception

          -  Able to communicate verbally

        Exclusion Criteria:

          -  Acute intracranial hemorrhage

          -  Ferrous metallic implanted objects in the skull or brain

          -  Prior toxicity with carboplatin chemotherapy

          -  Women who are pregnant or breastfeeding

          -  Cerebellar spinal cord or brain stem tumor

          -  Known active Hepatitis B or Hepatitis C or HIV

          -  Significant depression not adequately controlled

          -  Cardiac disease or unstable hemodynamics

          -  Severe hypertension

          -  History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor
             hemorrhage

          -  Active drug or alcohol use disorder

          -  Known sensitivity to gadolinium-based contrast agents

          -  Known sensitivity or contraindications to ultrasound contrast agent or perflutren

          -  Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted
             devices

          -  Difficulty lying supine and still or severe claustrophobia which cannot be managed
             with medication

          -  Severely impaired renal function

          -  Right to left or bi-directional cardiac shunt

          -  Cranial or systemic infection requiring antibiotics

          -  Known additional malignancy that is progression or require active treatment
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of Adverse Events
Time Frame:Through study completion, an average of 12 months
Safety Issue:
Description:All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:InSightec

Trial Keywords

  • Exablate
  • Focused Ultrasound
  • Carboplatin

Last Updated

July 30, 2020