177Lutetium-DOTATATE in Children with Primary Refractory or Relapsed High-risk Neuroblastoma
- Conditions
- NeuroblastomaNeuroblastoma Recurrent
- Interventions
- Combination Product: 177Lu-DOTATATE
- Registration Number
- NCT04903899
- Lead Sponsor
- Jakob Stenman
- 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 previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after ende of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 177Lu-DOTATATE 177Lu-DOTATATE A total of two doses of 177Lu-DOTATATE will be administered intravenously. The minimum time between treatments is 2 weeks.
- Primary Outcome Measures
Name Time Method Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 1 months after End of Treatment 1 months following end of treatment Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
- Secondary Outcome Measures
Name Time Method Progression-free survival Time from registration to progression or death, up to 5 years following end of treatment Time to progress or death, whichever occurs first
Number and severity of treatment-related adverse events Up to 5 years after end of treatment Number and severity of treatment-related adverse events
Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 4 months after End of Treatment 4 months following end of treatment Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)
Overall survival - up to 5 years after End of Treatment Time from registration to the the date of death, up to 5 years following end of treatment Overall survival
Trial Locations
- Locations (5)
Princess Maxima Center for Pediatric Oncology
🇳🇱Utrecht, Netherlands
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Vilnius University Hospital
🇱🇹Vilnius, Lithuania
Rigshospitalet
🇩🇰Copenhagen, Denmark
Oslo University Hospital, Rikshospitalet
🇳🇴Oslo, Norway