Actively Recruiting

Phase 2
Age: 18Months +
All Genders
NCT04903899

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

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 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.

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

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

K

Kleopatra Georgantzi, MD

CONTACT

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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