Actively Recruiting

Phase 2
Age: 18Months +
All Genders
ID04903899

A Phase II Trial of 177Lutetium-DOTATATE 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

260 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 multi-center clinical study investigating the use of 177Lu-DOTATATE in children with recurrent or relapsed high-risk neuroblastoma. This trial aims to assess how well this treatment works by measuring the response at 1 and 4 months after treatment ends. Secondary goals include evaluating survival rates, treatment-related side effects, and examining how tumor characteristics relate to treatment response. Participants receive two doses of 177Lu-DOTATATE administered intravenously, with at least two weeks between doses. The first dose is based on the patient's weight, while the second dose is adjusted using scans to control radiation exposure, particularly to avoid kidney toxicity. Patients must be prepared for autologous stem cell transplantation as part of this intensified treatment approach. During the study, participants will undergo various scans and laboratory tests before starting treatment and at scheduled times to monitor tumor response and side effects. Researchers will assess treatment effectiveness using established neuroblastoma response criteria and will follow patients for up to five years to monitor survival and any long-term effects. The total participation time includes treatment administration and extended follow-up for safety and outcomes.

CONDITIONS

Brief 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 diagnosis of neuroblastoma
  • Immunohistochemical staining for somatostatin receptors performed from primary tumor tissue when available
  • Relapsed or primary refractory high-risk neuroblastoma with INSS stage 4 or INRGSS stage M disease
  • Age greater than 18 months at enrollment
  • Life expectancy greater than 3 months
  • Karnofsky performance status over 50% for patients over 12 years old
  • Lansky performance status over 50% for patients 12 years old or younger
  • At least a two-week washout from any prior treatment
  • Recovery from hematological toxicity and major surgery before treatment
  • Uptake in tumor on 68Ga-DOTATATE PET/CT higher than liver uptake within two months prior to registration
  • 123I-mIBG scintigraphy within two months prior to registration
  • CT or MRI of primary tumor and bulky metastatic sites within two months prior to registration
  • Laboratory tests within 7 days before treatment: hemoglobin, neutrophil count, platelet count, liver enzymes, kidney function, and urinary catecholamine metabolites
  • Availability of peripheral blood stem cells with minimum CD34+ cell count prior to registration
  • Written informed consent from patient and/or parents or legal guardians
Not Eligible

You will not qualify if you...

  • Not fit enough for the proposed treatment as assessed by the principal investigator
  • Pregnant or lactating patients
  • Concurrent treatment with any anti-tumor agents
  • Prior treatment with other radiolabeled somatostatin analogues
  • Hypersensitivity to any component of 177Lutetium-DOTATATE
  • Treatment with long-acting somatostatin analogues within 30 days prior to treatment
  • Treatment with short-acting somatostatin analogues within 24 hours prior to treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At least 2 weeks

Participants receive two intravenous doses of 177Lu-DOTATATE with at least 2 weeks between treatments to target high-risk neuroblastoma.

2 treatment visits (in-person)

Follow-up

Duration - Up to 5 years

Participants are monitored for treatment response, adverse events, progression-free survival, and overall survival for up to 5 years after treatment ends.

Visits for assessments at 1 month and 4 months after treatment, then periodic visits up to 5 years

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