Recurrent Glioblastoma (rGBM) MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Carboplatino
Product Code: [NA]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: CARBOPLATINO
CAS Number: 41575-04-4
Current Sponsor code: NA
Con
Sponsors
INSIGHTEC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have histologically confirmed recurrent glioblastoma or clear MRI images of rGBM (T2/FLAIR abnormality consistent with tumor-associated edema that may also demonstrate additional features consistent with infiltrating high grade glioma e.g.: restricted diffusion; increase blood flow or volume on perfusion imaging) 2. Be =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Prior unacceptable toxicity with carboplatin therapy. 2. Subjects with cerebellar or brainstem tumor. 3. Subjects with diagnosis of immunodeficiency, known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected), or known positive HIV status. 4. Significant depression not adequately controlled with medication and at potential risk of suicide. Subjects on antipsychotic, antidepressants and benzodiazepines may be allowed to continue. Exposure of these medication will be limited for up to 48 hrs prior to ExAblate BBBD when medically feasible; patient will be monitored closely as indicated. 5. Has received anti-VEGF or anti-VEGFR targeted agents (e.g. bevacizumab, cedirinab, aflibercept, vandetanib, XL-184, sunitinib, etc). 6. Prior locally delivered therapies including chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, focal irradiation with brachytherapy, stereotactic radiosurgery, laser interstitial thermotherapy 7. Cardiac disease or unstable hemodynamics 8. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment 9. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage. 10. Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm or vasculitis. 11. 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. 12. Severely impaired renal function with estimated glomerular filtration rate 450 for men and >470 for women). 14. Has a known additional malignancy that is progressing or requires active treatment within 2 years of consent. Exceptions include malignancies treated with surgery alone including but not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Examples include, but are not limited to, active infection requiring systemic therapy or psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2.0/2.1 when used as a tool to disrupt the blood brain barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy;Secondary Objective: Not applicable;Primary end point(s): Safety Safety of the BBBD procedure will be evaluated through patient examination and magnetic resonance image (MRI) assessments during the treatment and during clinical visits. Serial clinic visits including physical and neurologic examination as well as periodic MRI scans will be used to continuously monitor safety post-BBBD procedures after adjuvant carboplatin monotherapy + Exablate BBBD is completed.;Timepoint(s) of evaluation of this end point: Refer to clinical protocol for timepoints | — |
Countries
Italy
Outcome results
None listed