Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients (NCT04446416) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients
Taiwan6 participantsStarted 2020-07-21
Plain-language summary
This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital. Eligible patients will be enrolled through the process of informed consent.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Adult male/female patients ≥ 20 years of age
✓. Patients with histologically confirmed glioblastoma, recurrent after prior radiotherapy and temozolomide chemotherapy.
✓. Patient may have been operated for recurrence. If operated: with measurable residual tumor
✓. Minimum interval since completion of radiation treatment is 12 weeks
✓. Patients if already on the steroids then should be on a stable dose of steroids for at least 7 days prior to study treatment
✓. Body mass index (BMI) ≥17 kg / m2
✓. Minimum interval since last drug therapy:
✓. Patients with life expectancy ≥ 3 months
Exclusion criteria
✕. Patients who have had previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab)
✕. New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening
✕. Severe hypertension at screening (diastolic blood pressure \> 100 mmHg on medication)
✕. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
✕. Unstable pulmonary disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening
✕. Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
✕. Major surgery such as intra-thoracic, intra-abdominal or intra-pelvic (with the exception of craniotomy), open biopsy or significant traumatic injury ≤ 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury
✕. Known HIV positive patients, however, that HIV testing is not required for entry into this study