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A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma LuDO-N
EU CTIS ID: 2023-503684-42-00
What this study is testing
To confirm the dose and assess response to single agent 177Lutetium-DOTATATE treatment in patients with relapsed or refractory high-risk neuroblastoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pathology: 1.1. Histologically confirmed diagnosis of neuroblastoma, 1.2 Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
- 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
- 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)
You likely can't join if
- Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the Lutathera 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
See the full eligibility criteria
Who can join
- Pathology: 1.1. Histologically confirmed diagnosis of neuroblastoma, 1.2 Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
- 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
- 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 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
What rules you out
- Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the Lutathera 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
- Hydronephrosis in either kidney on baseline MRI or CT; patients can still be eligible for inclusion if urinary tract obstruction can be ruled out by renography.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.