NeuroblastomaPhase 1NEUROBLU 02NCT03966651
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.
A Phase 1 study testing PRRT with 177Lu-DOTATATE in people with Neuroblastoma, run by Institut Claudius Regaud at 14 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- PRRT with 177Lu-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 14 sitesFrance
- Study dates
- 17 Apr 2023to 30 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan).
- Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen.
- Positive 68Ga-DOTATOC PET within 6 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.
- Patient for whom no effective conventional therapy exists.
- 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.
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- 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.
- Life expectancy greater than 3 months.
- Adequate performance Status defined as: Karnofsky or Lansky Play Performance Scale ≥ 50% (depending on patient's age).
- Adequate recovery from major surgery prior to receiving study treatment.
- 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).
- Patient must have adequate organ function as defined by the following values (within 6 weeks of first dose of study treatment):
- 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)
- 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)
- 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
- Cardiac function: Shortening fraction ≥ 28% or ejection fraction ≥ 55% by echocardiogram, with no clinical congestive heart failure associated. Normal pulmonary artery pressure.
- Patient assent and patients/parent(s)/legal guardian(s) written informed consent that is consistent with French law and ICH-GCP guidelines.
- 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).
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- 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)
- External Beam Radiation (EBR) therapy within 30 days before starting study treatment.
- Prior extensive EBR therapy:
- to more than 25% of the bone marrow;
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- for two kidneys : D50% (Right+ left kidneys) ≥15Gy and D30% (Right+ left kidneys) ≥ 20Gy" ; In case of a single remaining kidney (D50% ≥ 15Gy)
- 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.
- Other known co-existing malignancies.
- Hypersensitivity to 177Lu-DOTATOC, amino acid solution or 68GaDOTATATE.
- Pre-existing clinically significant hyperkalemia not adequately corrected.
- Participation in another study with an experimental molecule and/or procedure within 1 month prior to the first dose of experimental treatment.
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
- Childbearing or lactating patient.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CHU Angers
Angers
CHU Besançon
Besançon
CHU Pellegrin
Bordeaux
CHU Dijon
Dijon
CHU de Grenoble
Grenoble
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon
Hopital Arnaud de Villeneuve
Montpellier
CHU Nancy
Nancy
CHU Nantes
Nantes
CHU Reims
Reims
CHU Strasbourg
Strasbourg
CHU de Toulouse - Hôpital des enfants
Toulouse
IUCT-O
Toulouse
About this study
Official title: A 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.
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.
- Conditions
- Neuroblastoma
- Being tested
- PRRT with 177Lu-DOTATATE
- Keywords
- PRRT (Peptide Receptor Radionuclide Therapy), 177Lu-DOTATATE
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRRT with 177Lu-DOTATATEDrug
Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.
| Study group | Role | What they receive |
|---|---|---|
| PRRT with 177Lu-DOTATATE | Experimental | Not described Receives: Drug: PRRT with 177Lu-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE
Measured: 6 weeks for each patient
Secondary outcomes (1)
Safety will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events
Measured: 5 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start17 Apr 2023
- Primary completion8 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966651
- Sponsor's protocol ID
- 15 TETE 04
- Acronym
- NEUROBLU 02
- Status last verified
- Apr 2026
- First submitted
- 27 May 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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.
- ClinicalTrials.gov ID
- NCT03966651
- Acronym / sponsor ID
- NEUROBLU 02 / 15 TETE 04
- Conditions
- Neuroblastoma
- Keywords
- PRRT (Peptide Receptor Radionuclide Therapy), 177Lu-DOTATATE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRRT with 177Lu-DOTATATE | Experimental | Drug: PRRT with 177Lu-DOTATATE |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (26 listed)
- Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan).
- Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen.
- Positive 68Ga-DOTATOC PET within 6 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.
- Patient for whom no effective conventional therapy exists.
- 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):
Key exclusion criteria (14 listed)
- 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)
- External Beam Radiation (EBR) therapy within 30 days before starting study treatment.
- Prior extensive EBR therapy:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRRT with 177Lu-DOTATATEChildren will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval. | Drug | PRRT with 177Lu-DOTATATE |
Primary outcome
The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE
Time frame: 6 weeks for each patient
1 secondary outcome
Safety will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: 5 months for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRRT with 177Lu-DOTATATE in people with Neuroblastoma, run by Institut Claudius Regaud at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE (time frame: 6 weeks for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.