IRCT20170122032121N6
Completed
Phase 1
Evaluation of the safety of intrathecal injection of activated allogenic Natural Killer (NK) cells in pediatrics with brain gliomas; A phase I clinical trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Royan institute
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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