177Lu-DOTATATE treatment for children with high-risk neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The LuDO-N Trial is a multi-centre phase II clinical trial investigating the efficacy of 177Lu-DOTATATE in treating recurrent or relapsed high-risk neuroblastoma in children. This trial employs an intensified dosing schedule, administering two doses over a two-week period to maximize treatment effectiveness against this aggressive cancer. Patients will be monitored for treatment response at one and four months post-treatment, with additional assessments of survival rates and treatment-related toxicity. The study also aims to correlate tumor dosimetry and somatostatin receptor expression with treatment outcomes.

Why it matters

Who can join: the full rules

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 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 \> 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
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 registration
10. 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 Criteria:

1. 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.
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 177Lutetium-DOTATATE
6. Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE
7. 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

Where it's running

• Rigshospitalet
  Copenhagen, Copenhagen, Denmark Recruiting
• Vilnius University Hospital
  Vilnius, Vilnius County, Lithuania Recruiting
• Princess Maxima Center for Pediatric Oncology
  Utrecht, Utrecht, Netherlands Recruiting
• Oslo University Hospital, Rikshospitalet
  Oslo, Oslo, Norway Recruiting
• Pediatric Cancer Center Barcelona, Sant Joan de Déu Barcelona Children's Hospital
  Barcelona, Spain Recruiting
• Karolinska University Hospital
  Stockholm, Stockholm County, Sweden Recruiting

Study contacts

• Study coordinator: Jakob Stenman, MD PhD
• Email: jakob.stenman@regionstockholm.se
• Phone: (0)51770000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.