Recruiting

NEUROBLU 02177Lu-DOTATATE Safety in Children with Refractory Neuroblastoma

Study Aim

This study aims to determine the maximum safe dose of 177Lu-DOTATATE for treating children with difficult-to-treat neuroblastoma.

What is being tested

PRRT with 177Lu-DOTATATE

Drug

Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

From 1 to 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: April 2023

See protocol details

Summary

Principal SponsorInstitut Claudius Regaud

Study ContactFrédéric COURBON

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 17, 2023

Actual date on which the first participant was enrolled.

This clinical study aims to find the safest dose of a treatment called 177Lu-DOTATATE for children who have neuroblastoma that hasn't responded to other treatments or has come back. Neuroblastoma is a type of cancer that affects young children and can be difficult to treat, especially when it does not respond to standard therapies. The study focuses on children whose cancer cells have a specific feature called somatostatin receptors. By understanding the right dose of 177Lu-DOTATATE, researchers hope to provide a new and effective treatment option for these young patients. Participants in the study will receive the treatment through a vein in their arm, known as an intravenous infusion. The treatment is given in two cycles, with each cycle spaced six weeks apart. The main goal is to determine the highest dose that can be given without causing severe side effects, which is called the Maximum Tolerated Dose (MTD). The study will last for about five months for each child, and during this time, doctors will carefully monitor the participants to see how their bodies react to the treatment and to ensure their safety.

Official TitleA Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.

NCT03966651

Principal SponsorInstitut Claudius Regaud

Study ContactFrédéric COURBON

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, Neuroepithelial

Criteria

14 inclusion criteria required to participate

a) For dose levels 1 (80 MBq/kg) \& 2 (100 MBq/kg): Age \> 1 year and \< 18 years at the time of enrollment into the study.

Patient for whom no effective conventional therapy exists.

b) For dose level 3 (120 MBq/kg): \- If at least one patient \< 2 years old has been enrolled in one of the previous dose levels (80 or 100 MBq/kg): Age \> 1 year and \< 18 years at the time of enrollment into the study. \- If no patient \< 2 years old was enrolled in one of the previous dose levels (80 or 100 MBq/kg): Age ≥ 2 years and \< 18 years at the time of enrollment into the study.

Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan).

Show More Criteria

12 exclusion criteria prevent from participating

Childbearing or lactating patient.

Children with negative 68Ga-DOTATOC PET.

Chemotherapy within 4 weeks prior to the start of study treatment, high dose chemotherapy with stem cell transplantation within 3 months prior to start study treatment, long acting somatostatin analogues within 30 days prior to start of study treatment, biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first.

Any previous molecular radiotherapy (PRRT, 131ImiBG or other)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Recruiting

CHU Angers

Angers, FranceOpen CHU Angers in Google Maps

Recruiting

CHU Besançon

Besançon, France

Recruiting

CHU Pellegrin

Bordeaux, France

Recruiting

CHU Dijon

Dijon, France

Recruiting

14 Study Centers