Malignant neoplasm of brain. Malignant neoplasm of brain
Conditions
Interventions
Intervention group: All patients will be assigned to the single study intervention group and undergo suicide gene therapy using allogeneic mesenchymal stem cell carriers. The process of cellular carri
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age =18 years Karnofsky performance scale =70 Previous diagnosis of glioblastoma multiforme based on histopathological examination of the tumor specimen Complete course of standard treatment for GBM previously, including standard chemoradiotherapy regimen with or without surgical resection Tumor location accessible for stereotactic cell injection
Exclusion criteria
Exclusion criteria: Abnormal renal, hepatic, immunologic, and coagulation profile Active systemic infection Drug hypersensitivity following the use of ganciclovir Contraindication for magnetic resonance imaging Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity. Timepoint: Daily during the first 14 days after the injection and at 1-, 2- and 3-month after the injection. Method of measurement: Monitoring and evaluating the patients regarding the adverse events based on Common Terminology Criteria for Adverse Events (CTCAE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival. Timepoint: Every 2 months after the injection until death or end of study. Method of measurement: Patient monitoring and follow-up.;Progression-free survival. Timepoint: Every 2 months after the injection until death or end of study. Method of measurement: Magnetic resonance imaging and clinical evaluation of patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeed Oraee Yazdani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed