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.

NCT03966651 | Completed Phase 1

• 1 other identifier: 15 TETE 04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 14

Brief 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. The duration of study participation of each patient will be 5 months.

Conditions

Neuroblastoma

Keywords

PRRT (Peptide Receptor Radionuclide Therapy); 177Lu-DOTATATE

Outcome Measures

Primary Outcomes (1)

• The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE

  6 weeks for each patient

Secondary Outcomes (1)

• Safety will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events

  5 months for each patient

Study Arms (1)

PRRT with 177Lu-DOTATATE

EXPERIMENTAL

Drug: PRRT with 177Lu-DOTATATE

Interventions

PRRT with 177Lu-DOTATATE DRUG

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

PRRT with 177Lu-DOTATATE

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• \- 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)

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (14)

CHU Angers

Angers, France

Location

CHU Besançon

Besançon, France

Location

CHU Pellegrin

Bordeaux, France

Location

CHU Dijon

Dijon, France

Location

CHU de Grenoble

Grenoble, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

Hopital Arnaud de Villeneuve

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Reims

Reims, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU de Toulouse - Hôpital des enfants

Toulouse, France

Location

IUCT-O

Toulouse, France

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 29, 2019
• Study Start: April 17, 2023
• Primary Completion: August 8, 2024
• Study Completion: August 30, 2024
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (14)