Actively Recruiting

Phase 2
Age: 18Months +
All Genders
ID04903899

Phase II Trial of 177Lutetium-DOTATATE Treatment in Children With Primary Refractory or Relapsed High-risk Neuroblastoma

Led by Jakob Stenman · Updated on 2025-02-11

24

Participants Needed

5

Research Sites

521 weeks

Total Duration

On this page

Sponsors

J

Jakob Stenman

Lead Sponsor

A

Advanced Accelerator Applications

Collaborating Sponsor

AI-Summary

What this Trial Is About

The LuDO-N Trial is a phase II study focused on children with recurrent or relapsed high-risk neuroblastoma, a type of cancer. It aims to evaluate the response to treatment with 177Lu-DOTATATE, a radiolabeled drug, at 1 month and 4 months after treatment ends. The trial builds on prior experience, using an intensified dosing schedule to deliver two doses over two weeks, intending to maximize effects against this rapidly progressing disease. Researchers also want to study survival rates, treatment-related side effects, and relationships between tumor imaging and treatment response. Participants receive 177Lu-DOTATATE based on their weight, with the first dose set at 200 MBq per kg. The second dose is adjusted using scans to measure kidney radiation exposure, ensuring the total radiation remains within safe limits. The treatment plan includes careful monitoring of radiation doses to avoid kidney damage while aiming for an effective whole-body dose across two courses. During the study, children undergo various assessments including imaging scans such as 68Ga-DOTATATE PET/CT and 123I-mIBG scintigraphy, laboratory blood tests, and monitoring of kidney function. Researchers track treatment response using established neuroblastoma criteria one month after treatment completion. The study requires informed consent and readiness for stem cell transplantation. Treatment safety, tumor response, and survival outcomes are closely followed throughout the trial.

CONDITIONS

Official Title

177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma

Who Can Participate

Age: 18Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed neuroblastoma diagnosis
  • Immunohistochemical staining for somatostatin receptors performed if primary tumor tissue is available
  • Relapsed or primary refractory high-risk neuroblastoma with INSS stage 4 or INRGSS stage M disease
  • Age over 18 months at enrollment
  • Life expectancy greater than 3 months
  • Karnofsky performance status over 50% for patients older than 12 years
  • Lansky performance status over 50% for patients 12 years or younger
  • At least two weeks since prior treatment with recovery from hematological toxicity
  • Adequate recovery from major surgery before starting study treatment
  • Uptake in tumor deposits on 68Ga-DOTATATE PET/CT higher than liver within two months before registration
  • 123I-mIBG scintigraphy performed within two months before registration
  • CT or MRI of primary tumor and bulky metastatic sites within two months before registration
  • Laboratory tests within 7 days before treatment including hemoglobin, neutrophil count, platelets, bilirubin, liver enzymes, and kidney function meeting specified thresholds
  • Availability of a minimum of 2 x10^6 CD34+ cells/kg peripheral blood stem cells before registration
  • Written informed consent from patient and/or parent(s) or legal guardian(s)
Not Eligible

You will not qualify if you...

  • Not fit enough for study treatment as assessed by national principal investigator
  • Pregnant or lactating patients
  • Receiving any other anti-tumor treatments concurrently
  • Prior treatment with other radiolabeled somatostatin analogues
  • Known hypersensitivity to any component of 177Lutetium-DOTATATE
  • Treatment with long-acting somatostatin analogues within 30 days prior to study drug
  • Treatment with short-acting somatostatin analogues within 24 hours prior to study drug

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Rigshospitalet

Copenhagen, Copenhagen, Denmark, DK-2100

Actively Recruiting

2

Vilnius University Hospital

Vilnius, Vilnius County, Lithuania, LT-08406

Actively Recruiting

3

Princess Maxima Center for Pediatric Oncology

Utrecht, Utrecht, Netherlands, NL-3584

Actively Recruiting

4

Oslo University Hospital, Rikshospitalet

Oslo, Oslo, Norway, NO-0372

Actively Recruiting

5

Karolinska University Hospital

Stockholm, Stockholm County, Sweden, SE-171 76

Actively Recruiting

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Research Team

J

Jakob Stenman, MD PhD

K

Kleopatra Georgantzi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

A Phase II Trial of a Personalized, Dose-Intense Administration Schedule of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-Risk Neuroblastoma-LuDO-N.

Fredrik Sundquist, Kleopatra Georgantzi, Kirsten Brunsvig Jarvis...

https://pubmed.ncbi.nlm.nih.gov/35359899