High grade brain glioma. Malignant neoplasm of brain
Conditions
Interventions
Intervention 1: Intervention group: Patients in intervention group will receive 200 millions NK cells via intrathecal injection (LP or resorvor) for 3 times. In cases who have ongoing surgery or have
Sponsors
Kian immune cell company
Royan institute
Eligibility
Sex/Gender
All
Age
3 Years to 60 Years
Inclusion criteria
Inclusion criteria: New diagnosed patients with grade 3 or 4 brain tumor, based on WHO classification, which are included in the one of the following conditions: • Astrocytoma, IDH-mutant • Oligodendroglioma, IDH-mutant • Glioblastoma, IDH-wild type • Diffuse midline glioma • Diffuse hemispheric glioma • Diffuse pediatric-type high-grade glioma, IDH-wild type Age range of 3 to 60 years old both sex Lansky/Karnofsky performance score above 60 Obtained informed consent of patients or parents or legal attendance in cases of pediatrics Hemoglobin above 10 gr/dL of blood Absolute granulocyte count (AGC) above 500 per microliter of blood Platelet count above 50000 per microliter of blood INR below 2 and PTT less than 1.5 times of maximum normal value Plasma bilirubin level less than 1.5 times of maximum normal value Plasma hepatic transaminases (ALT and AST) level less than 3 times of maximum normal value Plasma creatinine level less than 1.5 times of maximum normal value
Exclusion criteria
Exclusion criteria: Evidence of radio necrosis in MRI or MRS Intolerance of new treatment due to emergency condition History of other malignancies History of any immunodeficiency diseases or any immune compromising conditions Rupture of cerebral shunt or unable to perform a lumbar puncture Pregnancy History of uncontrolled chronic diseases such as: Diabetes, CHF, liver cirrhosis, CKD, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate comparison between control and intervention groups. Timepoint: 1 to 2 weeks after last injection with the follow up of 3, 6, and 12 months after last injection. Method of measurement: Using iRANO (Immunotherapy Response Assessment in Neuro-Oncology) checklist and using MRI and MRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety. Timepoint: After each injection to next injection and 2 weeks after last injection. Method of measurement: Using CTCAEs (Common Terminology Criteria for Adverse Events) checklist.;Overall survival and progression-free survival. Timepoint: After the end of the study. Method of measurement: using Kaplan-Meier method.;Analysis of CSF including: hematology, biochemistry, culture, cytokine level and immunophenotype of cells. Timepoint: Before each injection, CSF sample will be taken from patients for analysis. Method of measurement: using microscope and slides, spectrophotometer, enzyme assay, ELISA and Flowcytometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Mahdizadeh
Royan institute & Kian immune cell company
Outcome results
None listed