Brain glioma. Malignant neoplasm of brain
Conditions
Interventions
Intervention group: 40-50 million activated allogenic NK cells will be injected intrathecally every week till five injection. In cases of response to the treatment, five more injections will be planne
Sponsors
Royan institute
Kian Immune Cell company
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: patients with diagnosis of brain stem glioma, DIPG, unresectable glioma, and relapsed-refractory glioma Age between 3 to 18 years old Hemoglobin level above 10 gr/deciliter of blood Absolute granulocyte count (AGC) above 1500 per microliter of blood Platelet count above 100000 per microliter of blood Lansky (for under 16 years old) or Karnofsky (for above 16 years old) performance score above 60 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 2/5 times of maximum normal value Plasma Creatinine level less than 1/5 times of maximum normal value Informed consent of parents or legal attendance
Exclusion criteria
Exclusion criteria: evidence of radio necrosis in MRI or MRS intolerance of new treatment due to emergency condition rupture of cerebral shunt or unable to perform a lumbar puncture (LP) history of other malignancies history of any immunodeficiency diseases or any immune compromising conditions occurrence of new neurologic lesion after first injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of intrathecal injection of Natural Killer (NK) cells. Timepoint: safety will be measured after each injection till 24 hour in hospital for acute adverse events. Other adverse events will be recorded in periodical follow up in 1, 3, 6, and 12 month after the last injection. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAEs) checklist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of tumor size. Timepoint: Tumor size will be measured before the first injection and after fifth and tenth injection it will be measured again. 3 month, 6 month and 12 month after the last injection the size will be measured ordinally. Method of measurement: MRI (with and without contrast and DWI method) and MRS.;Overall survival and progression-free survival. Timepoint: At the end of the study the survivals will be measured for patients. Method of measurement: Kaplan-Meier method.;Cerebrospinal fluid (CSF) analysis (cytokine changes, hematology, and biochemistry). Timepoint: Before each injection, samples of CSF will be taken and will sent to lab for analysis. Method of measurement: ELISA, Spectrophotometry, microscopic study. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Mahdizadeh
Royan institute
Outcome results
None listed