A 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.

Study Purpose

This study is a multicenter, open label phase I dose escalation trial designed to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE in children with refractory or recurrent neuroblastoma. 177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart. The duration of study participation of each patient will be 5 months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Year - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan). 2. Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen. 3. Positive 68Ga-DOTATOC PET within 4 weeks prior to day 1 dosing. Note: PET positivity is visually defined as follow: uptake should be equivalent or higher than the liver uptake for all lesions identified by conventional neuroblastoma imaging working. 4. Patient for whom no effective conventional therapy exists. 5. 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. 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.
6. Life expectancy greater than 3 months. 7. Adequate performance Status defined as:
  • - ECOG < 2 (for patients >12 years of age) - Lansky Play Performance Scale 50% or more (for patients <12 years of age) 8.
Adequate recovery from major surgery prior to receiving study treatment. 9. Patients must have recovered (to CTCAE grade 1 or baseline) from any acute toxicity resulting from any prior anti-cancer treatment (except alopecia and ototoxicity). 10. Patient must have adequate organ function as defined by the following values (within 1 week of first dose of study treatment): 1. Bone marrow function: If no bone marrow disease: Platelets ≥ 100 x 109/L (unsupported for 72 hours) Absolute Neutrophil Count (ANC) ≥ 0.75 x 109/L Hemoglobin > 7.5 g/dL (transfusions are allowed) In case of bone marrow disease: Platelets ≥ 75 x109/L (unsupported for 72 hours) ANC ≥0.5 x 109/L Hemoglobin > 7.5 g/dL (transfusions are allowed) 2. Renal function: Serum creatinine ≤1.5 ULN for age; if higher, a calculated Glomerular Filtration Rate (GFR) (2009 Schwartz formula*) must be ≥ 60 ml/min/1.73 m2. * eGFR (mL/min/1,73 m²) = height (cm) x 36,5 / serum creatinine (µmol/L) 3. Liver function: AST and ALT ≤2.5 ULN and total bilirubin ≤1.5 ULN. In case of liver metastases, AST and ALT ≤5 ULN and total bilirubin ≤2.5 ULN. 4. Cardiac function: Shortening fraction ≥ 28% or ejection fraction ≥ 55% by echocardiogram, with no clinical congestive heart failure associated. Normal pulmonary artery pressure. 11. Patient assent and patients/parent(s)/legal guardian(s) written informed consent that is consistent with French law and ICH-GCP guidelines. 12. Patients with reproductive potential (girls post menarche and males after 1st ejaculation) and sexually active must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 7 months (for females) or 4 months (for males) after completion of study drug therapy (in accordance with CTFG guidelines). 13. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Children with negative 68Ga-DOTATOC PET. 2. 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. 3. Any previous molecular radiotherapy (PRRT, 131ImiBG or other) 4. External Beam Radiation (EBR) therapy within 30 days before starting study treatment. 5. Prior extensive EBR therapy:
  • - to more than 25% of the bone marrow; - to both kidneys (except if scatter absorbed doses of < 0.5Gy to a single kidney or radiation to <50% of a single kidney).
6. Known brain metastases, unless these metastases have been treated and stabilized for at least 3 months prior to enrolment in the study. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable disease prior to enrolment in the study. 7. Other known co-existing malignancies. 8. Hypersensitivity to 177Lu-DOTATOC, amino acid solution or 68GaDOTATATE. 9. Pre-existing clinically significant hyperkalemia not adequately corrected. 10. Participation in another study with an experimental molecule and/or procedure within 1 month prior to the first dose of experimental treatment. 11. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. 12. Childbearing or lactating patient.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut Claudius Regaud
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Arms & Interventions


Experimental: PRRT with 177Lu-DOTATATE


Drug: - PRRT with 177Lu-DOTATATE

Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Oscar Lambret, Lille, France


Not yet recruiting


Centre Oscar Lambret

Lille, ,

Site Contact



03 20 29 59 59

Centre Léon Bérard, Lyon, France


Not yet recruiting


Centre Léon Bérard

Lyon, ,

Site Contact



04 69 85 60 01

CHU de Toulouse - Hôpital des enfants, Toulouse, France




CHU de Toulouse - Hôpital des enfants

Toulouse, ,

Site Contact



05 34 55 84 26

IUCT-O, Toulouse, France





Toulouse, ,

Site Contact

Frédéric COURBON


+33 5 31 15 55 26

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