K cell therapy in pediatrics with brain glioma

Phase 1

Conditions: Brain glioma.
Malignant neoplasm of brain

Registration Number: IRCT20170122032121N6

Lead Sponsor: Royan institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 10

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.