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.
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Carboplatin | Exablate BBBD with carboplatin |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Exablate BBBD with carboplatin | Experimental | 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. |
|
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 |
| 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 |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | InSightec |
May 21, 2021
