Recurrent Glioblastoma
Conditions
Keywords
Exablate, Focused Ultrasound, rGBM
Brief summary
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 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.
Interventions
DRUGCarboplatin
Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
DEVICEExablate BBBD
BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through study completion, an average of 12 months | All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria. |
| Contrast intensity on MR imaging | Immediately after Exablate BBBD procedure | BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging |
Countries
United States
Outcome results
None listed