Glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Temozolomide
Product Code: [NA]
Pharmaceutical Form: Gastro-resistant capsule
INN or Proposed INN: TEMOZOLOMIDE
CAS Number: 85622-93-1
Current Sponsor code: NA
Concentration unit: mg mil
Sponsors
INSIGHTEC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is eligible for adjuvant TMZ treatment based on the current standard of care. 2. Men or women age between 18 and 80 years, inclusive. 3. Able and willing to give informed consent. 4. Grade IV glioma (GBM) confirmed through assessment of surgical specimens by a board-certified neuropathologist. 5. Maximal surgical debulking of the tumor was performed. 6. Combined radiation/TMZ treatment is completed based on the prescribed standard of care regimen. 7. Karnofsky rating 70-100 (See Appendix B). 8. Able to communicate during the Exablate BBBD procedure. 9. Life expectancy of at least 3 months. 10. Contraceptive use by both male and female subjects consistent with local regulations regarding the methods of contraception for those participating in clinical studies (See section 2.5 point 10). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Patients presenting with the following imaging characteristics: i. Evidence of acute intracranial hemorrhage. 2. The sonication pathway to the tumor involves: i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. 3. The subject presents with severe symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema). 4. Sever midline shift or evidence of subfalcine, uncal, or tonsillar herniation on pre-procedure imaging. 5. Patients with cerebellar or brainstem tumors. 7. Significant depression not adequately controlled with medication and at potential risk of suicide. 8. Patients with brain tumors containing 1p/19q chromosomal co-deletion (consistent with oligodendroglioma). 9. Patient receiving bevacizumab (Avastin) therapy. 10. Patients receiving treatment with corticosteroid doses greater than dexamethasone 24mg daily (or equivalent). 11. Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, focal irradiation with brachytherapy, stereotactic radiosurgery, laser interstitial thermotherapy, and tumor treatment fields therapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence [35] [36], [37-39]. 12. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment). 13. History of a bleeding disorder and/or coagulopathy. 14. Abnormal level of platelets ( 1.3. 15. Cerebral vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis. 16. Evidence of new focal neurological deficits including, but not limited to, motor weakness or speech impairment within 7-14 days prior to the first BBBD procedure. 17. Severely impaired renal function with estimated glomerular filtration rate 1.3; bilirubin >5 times lab normal).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and feasibility of Blood Brain Barrier (BBB) disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant Temozolomide (TMZ) chemotherapy,;Secondary Objective: Not applicable;Primary end point(s): Safety: Safety of the BBBD procedure will be evaluated through patient examination and MRI assessments during the treatment and by their standard of care follow-up MRI scans and clinical visits. The standard of care follow-up MRI scans will be used to continue safety monitoring post-BBBD procedures and after adjuvant TMZ chemotherapy is completed. Feasibility: Feasibility of BBBD will be evaluated through assessment of post-sonication contrast-enhanced MR imaging and comparing it with pre-sonication imaging. The relative increase in the amount of contrast uptake within the sonicated region will be used as a measure of the extent of BBB disruption due to sonication. A comparison of the MRI findings of changes in tumor progression compared to other similar tumor regions within the same patient will be evaluated using standard of care MR imaging.;Timepoint(s) of evaluation of this end point: Refer to clinical protocol synopsis for timepoints | — |
Countries
Italy, Spain
Outcome results
None listed