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

Not Applicable

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Paediatric Oncology; Disease: Brain and Nervous System; Cancer

• Registration Number: ISRCTN98918118
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32157433 (added 12/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-20
• Study Completion: 2015-04-01
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate; Timepoint(s): 1 month

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall survival; Timepoint(s): Follow up for 5 years<br> 2. Progression-free survival; Timepoint(s): Follow up for 5 years<br> 3. Toxic effects<br>