Malignant brain glioblastoma. Malignant neoplasm of brain
Conditions
Interventions
Intervention 1: Intervention group: In the intervention group, patients will be treated with a low dose of bevacizumab (5 mg/kg). Intervention 2: Control group: In the control group, patients will be
Sponsors
Sabzevar University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years and above Confirmed WHO grade IV histological diagnosis of glioblastoma First or second relapse after standard treatment including surgery, radiotherapy, and temozolomide Radiological evidence of disease progression based on Rano criteria Karnefsky performance score of more than 60 percent At least 4 weeks since the last surgery At least 12 weeks after the end of radiotherapy Optimal liver, kidney and bone marrow function Normal blood coagulation Written informed consent
Exclusion criteria
Exclusion criteria: Previous use of bevacizumab or other VEGF inhibitors Early disease progression (less than 3 months after radiotherapy) More than two prior lines of chemotherapy Expanded leptomeningeal disease History of intracerebral hemorrhage in the past 6 months Uncontrolled hypertension Significant proteinuria History of recent thromboembolism (past 6 months) Pregnancy or lactation History of other malignancy in the past 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival. Timepoint: Every 8 weeks after the intervention. Method of measurement: brain imaging and physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival. Timepoint: Every three months after intervention. Method of measurement: Patient follow-up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Alireza Javadinia
Sabzevar University of Medical Sciences
Outcome results
None listed