IRCT20170122032121N6已完成1 期
Evaluation of the safety of intrathecal injection of activated allogenic Natural Killer (NK) cells in pediatrics with brain gliomas; A phase I clinical trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3 years 至 18 years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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