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

Phase 2

Recruiting

• Conditions: cancer of the nervous system; Neuroblastoma; 10029211

• Registration Number: NL-OMON51935
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

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 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. AST within 2.5 x ULN
8.2.4. GGT within 5 x ULN
8.2.5. ALP within 5 x ULN
8.2.6. Glomerular filtration rate >50mL/min/1.73m2 assessed by a recognised
method, such as
inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months
prior to registration
8.2.7. Urinary catecholamine metabolites measured within 2 months prior to
registration
9. Peripheral blood stem cells (PBSC)
9.1. A minimum of 2 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must
be available for
each study subject prior to registering
10. Written informed consent from patient and/or parent(s) or legal guardian(s)

Exclusion Criteria

1. Not fit enough to undergo proposed study treatment, as assessed by national
PI, considering
precautions defined in the latest version of the Lutathera SmPC
2. Pregnant or lactating patient
3. Concurrent treatment with any anti-tumor agents
4. Prior treatment with other radiolabeled somatostatin analogues
5. Hypersensitivity to any component of the investigational drug Lutathera®
6. Treatment with long-acting somatostatin analogues within 30 days prior the
administration of
Lutathera®

Study & Design

• Study Type: Interventional
• Study Design: Not specified