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Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

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InSightec

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Recurrent Glioblastoma

Treatments

Device: Exablate BBBD
Drug: Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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 with microbubble resonators. 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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/asent
  • Tumor progression after first line chemo radiation
  • 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
  • Has previously received anti-VEGF or anti-VEGF agents like Avastin
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Exablate BBBD with carboplatin
Experimental group
Description:
Carboplatin 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.
Treatment:
Drug: Carboplatin
Device: Exablate BBBD

Trial contacts and locations

4

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Central trial contact

Kathy McDermott; Julia Zhu

Data sourced from clinicaltrials.gov

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