Status:
RECRUITING
177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
Lead Sponsor:
Jakob Stenman
Collaborating Sponsors:
Advanced Accelerator Applications
Novartis
Conditions:
Neuroblastoma Recurrent
Neuroblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the ...
Eligibility Criteria
Inclusion
- Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
- Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
- Age \>18 months at the time of enrolment into this study
- Life expectancy of greater than 3 months
- Performance Status 5.1. Karnofsky \> 50% (for patients \> 12 years of age) 5.2. Lansky \> 50% (for patients ≤ 12 years of age)
- 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
- 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
- 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 \> 50 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
- 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 registration
- Written informed consent from patient and/or parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures
Exclusion
- Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the 177Lutetium-DOTATATE SmPC.
- Pregnant or lactating patient
- Concurrent treatment with any anti-tumor agents
- Prior treatment with other radiolabeled somatostatin analogues
- Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE
- Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2031
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04903899
Start Date
May 19 2021
End Date
May 20 2031
Last Update
February 11 2025
Active Locations (5)
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1
Rigshospitalet
Copenhagen, Copenhagen, Denmark, DK-2100
2
Vilnius University Hospital
Vilnius, Vilnius County, Lithuania, LT-08406
3
Princess Maxima Center for Pediatric Oncology
Utrecht, Utrecht, Netherlands, NL-3584
4
Oslo University Hospital, Rikshospitalet
Oslo, Oslo County, Norway, NO-0372