Trial investigating the activity of 177 Lutetium dotatate in children with cancer in their nervous system

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The trial will evaluate how effective 177Lutetium DOTATATE is in children with high-risk relapsed or refractory neuroblastoma and determine the safety and adverse events of the treatment experienced by patients on the study.;Secondary Objective: The trial aims to determine whether there is a relationship between the absorbed dose to the tumour and response to 177Lutetium DOTATATE. To correlate the somatostatin receptor sub-type 2 expression in the original histology specimens from primary surgery with 68Gallium DOTATATE PET/CT uptake (SUVmax values) To correlate the uptake on 68Gallium DOTATATE PET/CT by SUVmax scores with response to 177Lutetium DOTATATE therapy.;Primary end point(s): Response rate by International Neuroblastoma Response Criteria at one month after the completion of therapy.;Timepoint(s) of evaluation of this end point: Evaluated at 1 month, 4 months, and then every 6 months until progression

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ToxicityProgression free survival Overall survival Response rate by International Neuroblastoma Response criteria at four months after completion of therapy.;Timepoint(s) of evaluation of this end point: Toxic effects - To be evaluated during treatment at 1 month and 4 months post therapy or until all treatment related events have resolved. Progression free survival - at point of relapse Overall survival - up to 5 years of completion of therapy.