Neuroblastoma
Conditions
Interventions
Product Name: Lutetium-177 DOTATATE
Product Code: n/a
Pharmaceutical Form: Radiopharmaceutical precursor, solution
INN or Proposed INN: Lutetium-177 DOTATATE
Current Sponsor code: RG_11-141
Concentrat
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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 12 years of age) Lansky 50% or more (for patients 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Contacts
Public ContactNicola Graham
University of Birmingham
Outcome results
None listed