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.
NCT ID: NCT03966651
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2023-04-17
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart.
The duration of study participation of each patient will be 5 months.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
NCT06441331
Dosimetry Guided PRRT With 177Lu-DOTATATE in Children and Adolescents
NCT03923257
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
NCT00049023
Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy
NCT00001565
177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
NCT04903899
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PRRT with 177Lu-DOTATATE
PRRT with 177Lu-DOTATATE
Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRRT with 177Lu-DOTATATE
Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen.
3. 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.
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: Karnofsky or Lansky Play Performance Scale ≥ 50% (depending on patient's 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 6 weeks 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
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;
* for two kidneys : D50% (Right+ left kidneys) ≥15Gy and D30% (Right+ left kidneys) ≥ 20Gy" ; In case of a single remaining kidney (D50% ≥ 15Gy)
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.
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Institut Claudius Regaud
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
CHU Pellegrin
Bordeaux, , France
CHU Dijon
Dijon, , France
CHU de Grenoble
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
CHU Nancy
Nancy, , France
CHU Nantes
Nantes, , France
CHU Reims
Reims, , France
CHU Strasbourg
Strasbourg, , France
CHU de Toulouse - Hôpital des enfants
Toulouse, , France
IUCT-O
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15 TETE 04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.