A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Pathology
1.1. Histologically confirmed diagnosis of neuroblastoma
1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available

2. Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease

3. Age >18 months and < 18 years of age at the time of enrolment into this study

4. Life expectancy of greater than 3 months

5. Performance Status
5.1. Karnofsky > 50% (for patients > 12 years of age)
5.2. Lansky > 50% (for patients = 12 years of age)

6. Prior treatment
6.1. Two-week washout from any prior treatment
6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study treatment

7. Diagnostic imaging
7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET/CT at least higher than the liver uptake and performed within two months prior to registration
7.2. 123I-mIBG scintigraphy to be performed within two months prior to registration
7.3. CT or MRI of the primary tumor and bulky metastatic sites within two months prior to registration

8. Laboratory requirements to be performed within 7 days prior to commencing trial treatment:
8.1. Hematology:
8.1.1. Hemoglobin, If Hb is <120 g/L then patient will receive a blood transfusion prior to commencing trial treatment
8.1.2. Absolute neutrophil count > 1.0 x 109/L 8.1.3. Absolute Platelets > 100 x 109/L
8.2. Biochemistry:
8.2.1. Bilirubin within 1.5 x ULN
8.2.2. ALT within 2.5 x ULN
8.2.3. ALP within 5 x ULN
8.2.4. Glomerular filtration rate >50mL/min/1.73m2 assessed using Iohexol clearance or creatinine clearance and performed within 2 months prior to registration
8.2.5. Urinary catecholamine metabolites measured within 2 months prior to registration

9. Peripheral blood stem cells (PBSC)
9.1. A minimum of 4 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registering

10. Parents or appointed legal guardian to sign the written informed consent prior to registration or any trial-related screening procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Not fit enough to undergo proposed study treatment, as assessed by national PI

2. Pregnant or lactating patient

3. Concurrent treatment with any anti-tumor agents

4. Prior treatment with other radiolabeled somatostatin analogues

5. 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

6. Hypersensitivity to any component of the investigational drug Lutathera®

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method