EUCTR2012-000510-10-GB进行中（未招募）1 期
A Phase IIa trial of 177 Lutetium Dotatate in Children with Primary Refractory or Relapsed High-Risk Neuroblastoma - LuDo
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically confirmed diagnosis of neuroblastoma - Relapsed or primary refractory high risk neuroblastoma (International Neuroblastoma Staging System stage 4 or International Neuroblastoma Risk Group staging System M) - Age >18 months and <18 years of age at the time of enrolment into the study - Life expectancy of greater than 3 months - Performance Status: Karnofsky 50% or more (for patients >12 years of age) Lansky 50% or more (for patients <12 years of age) - Adequate recovery from major surgery prior to receiving study treatment - Uptake in primary tumour or metastatic tumour deposits on 68Gallium DOTATATE PET/CT at least as high as the liver uptake and performed within a month prior to trial - I-MIBG and FDG PET/CT within a month prior to trial entry - Two week washout from any prior treatment - Patients must have recovery of hematological toxicity following previous therapy - Laboratory requirements within 7 days of commencement of therapy • Haemoglobin, If Hb is <12g/dl then patient will receive a blood transfusion prior to treatment • Absolute neutrophil count > 1.0 x 10^9/L • Absolute Platelets > 100 x 10^9/L Biochemistry: • Bilirubin within normal range • ALT within 2.5 x ULN • ALP within 5 x ULN - Glomerular Filtration rate >50mL/min/1.73m2 - Before patient registration, written informed consent. - Parents or other appropriate adult to sign the local Comforters and Carers consent before patient registration. - Agreed to a follow up of 5 years.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Not fit enough to undergo proposed study treatment - Concurrent treatment with any anti-tumour agents - Prior treatment with other radiolabelled somatostatin analogues - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient or legal guardian before registration in the trial
研究者
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