A Phase IIa trial of 177 177 lutetium dotatate in children with primary refractory or relapsed high-risk neuroblastoma

niversity of Birmingham (UK)0 个研究点目标入组 21 人开始时间: 2013年12月20日最近更新: 2020年3月30日

适应症

试验速览

•1. Histologically confirmed diagnosis of neuroblastoma
•2. Relapsed or primary refractory high-risk neuroblastoma (International Neuroblastoma Staging System stage 4 or International Neuroblastoma Risk Group staging System M)
•3. Age >18 months and <18 years of age at the time of enrolment into the study
•4. Life expectancy of greater than 3 months
•5. Performance Status:
•5.1. Karnofsky 50% or more (for patients >12 years of age)
•5.2. Lansky 50% or more (for patients <12 years of age)
•5.3. Adequate recovery from major surgery prior to receiving study treatment
•5.4. 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
•5.5. IMIBG and FDG PET/CT within a month prior to trial entry
•5.6. Two-week washout from any prior treatment
•5.7. Patients must have recovery of hematological toxicity following previous therapy
•6. Laboratory requirements within 7 days of commencement of therapy
•6.1. Absolute neutrophil count > 1.0 x 10^9/L
•6.2. Absolute platelets > 100 x 10^9/L
•7. Biochemistry:
•7.1. Bilirubin within normal range
•7.2. ALT within 2.5 x ULN
•7.3. ALP within 5 x ULN
•7.4. Glomerular filtration rate >50 mL/min/1.73m2
•8. Before patient registration, written informed consent
•9. Parents or other appropriate adult to sign the local Comforters and Carers consent before patient registration
•10. Agreed to a follow-up of 5 years.

•1. Not fit enough to undergo proposed study treatment
•2. Concurrent treatment with any antitumour agents
•3. Prior treatment with other radiolabelled somatostatin analogues
•4. 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

发起方

niversity of Birmingham (UK)