Evaluation of the safety and feasibility of stem cell-mediated gene therapy in the treatment of glioblastoma
Phase 1
- Conditions
- Glioma grade 4.Malignant neoplasm of brain
- Registration Number
- IRCT20200502047277N2
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Karnofsky performance status> 70.
Adequate hematological function (an absolute neutrophil count > 1500/µl and platelet count > 125000/mm3).
Adequate renal function (creatinine < 1.5 times the normal).
Adequate hepatic function (aspartate aminotransferase and bilirubin < 1.5 times the normal).
Patient who fill informed consent.
Exclusion Criteria
Significant vascular disease.
History of recurrent thromboembolism.
Prior history of hypertensive crisis or hypertensive encephalopathy.
Gastrointestinal fistula or perforation.
History of intraabdominal or intracranial abscess within 6 months.
Serious non healing wound, ulcer and bone fracture.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS) of patients. Timepoint: Before treatment and every three months until the patient's death. Method of measurement: The time from treatment initiation until patient's death.;Radiological progression free survival (PFS) of patients. Timepoint: Before treatment and every three months until the disease recurrence. Method of measurement: The time from treatment initiation until disease progression or worsening.
- Secondary Outcome Measures
Name Time Method