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Study on the Safety of Lutetium (177Lu) Oxodotreotide with Arginine and Lysine in Children with Refractory or Recurrent Neuroblastoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for neuroblastoma, a type of cancer that most commonly affects children. The study is specifically for children whose neuroblastoma has either come back after treatment or has not responded to previous treatments. The treatment being tested is called Peptide Receptor Radionuclide Therapy (PRRT) using a medication known as 177Lu-DOTATATE. This medication is given as a solution through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to find out the highest dose of 177Lu-DOTATATE that can be given safely to children with neuroblastoma. During the study, children will receive the medication and be closely monitored to see how their bodies react to it. The study will also look at how safe the treatment is and how it affects the cancer. Another medication, LysaKare, which contains arginine hydrochloride and lysine hydrochloride, may also be used to help protect the kidneys during the treatment.

Participants in the study will receive the treatment over a period of time and will have regular check-ups to monitor their health and the effects of the treatment. The study aims to gather important information that could help improve treatment options for children with neuroblastoma in the future. A placebo may be used in some parts of the study to compare the effects of the treatment. The study is expected to continue until 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Tests may include blood tests, imaging scans, and other evaluations to ensure adequate organ function and overall health.

  2. Step 2

    Treatment preparation

    Before starting treatment, preparation involves ensuring that all necessary conditions are met, such as adequate recovery from previous treatments and confirmation of neuroblastoma diagnosis.

    Consent forms are reviewed and signed by the patient or guardian.

  3. Step 3

    First treatment cycle

    The first cycle of treatment begins with the administration of LysaKare 25 g/25 g solution for infusion. This is given intravenously to protect the kidneys during the main treatment.

    Following this, Lutathera 370 MBq/mL solution for infusion is administered intravenously. The dosage is determined based on the patient's weight and specific dose level assigned (80 MBq/kg, 100 MBq/kg, or 120 MBq/kg).

  4. Step 4

    Monitoring and evaluation

    After the first treatment, monitoring occurs to assess the body's response and any side effects. This includes regular blood tests and imaging scans.

    The primary focus is to determine the Maximum Tolerated Dose (MTD) of the treatment, which involves observing any dose-limiting toxicities over a six-week period.

  5. Step 5

    Subsequent treatment cycles

    If the initial treatment is tolerated well, additional cycles may be administered. The frequency and number of cycles depend on the patient's response and overall health.

    Each cycle involves the same process of kidney protection with LysaKare followed by Lutathera infusion.

  6. Step 6

    Follow-up and final assessment

    After completing the treatment cycles, follow-up assessments are conducted to evaluate the effectiveness of the treatment and monitor long-term health.

    This includes measuring the Objective Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS) to determine the treatment's impact on the neuroblastoma.

Who can join the trial?

16 criteria

  • The patient must have a confirmed diagnosis of **neuroblastoma**, a type of cancer that affects nerve tissue.
  • The patient must have **adequate organ function**, which means their organs are working well enough to handle the treatment. This includes:
    • **Bone marrow function**: If there is no disease in the bone marrow, the patient must have enough platelets and a certain level of white blood cells and hemoglobin. If there is disease in the bone marrow, the requirements are slightly lower.
    • **Renal function**: The kidneys must be working well, as shown by a test called **serum creatinine** or a calculated **Glomerular Filtration Rate (GFR)**.
    • **Liver function**: The liver must be working well, shown by tests called **AST**, **ALT**, and **bilirubin** levels.
    • **Cardiac function**: The heart must be working well, shown by tests called **shortening fraction** or **ejection fraction**.
    • The patient and their parents or guardians must give written consent to participate, following French law and international guidelines.
    • If the patient is able to have children, they must agree to use effective birth control during the study and for a period after the study ends.
    • The patient must be covered by Social Health Insurance in France.
    • The patient must have **recurrent or refractory neuroblastoma**, meaning the cancer has come back or is not responding to standard treatments, after at least two previous treatments.
    • The patient must have a positive result on a specific scan called **68Ga-DOTATOC PET** within 6 weeks before starting the study treatment.
    • There must be no other effective conventional therapy available for the patient.
    • The patient must be between 1 and 18 years old, depending on the dose level they are eligible for.
    • The patient must have a life expectancy of more than 3 months.
    • The patient must have an **adequate performance status**, which means they are well enough to carry out daily activities, as measured by a specific scale.
    • The patient must have recovered from any major surgery before starting the study treatment.
    • The patient must have recovered from any side effects of previous cancer treatments, except for hair loss and hearing problems.

Who cannot join the trial?

7 criteria

  • Patients who do not have a diagnosis of recurrent or refractory neuroblastoma cannot participate. Recurrent means the cancer has come back after treatment, and refractory means the cancer does not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study is for children.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
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Investigated drugs

177Lu-DOTATATE is a type of targeted therapy used in this clinical trial. It involves a radioactive substance that is linked to a molecule designed to attach to specific receptors on cancer cells. In this study, it is used to treat children with neuroblastoma, a type of cancer that has returned or is not responding to other treatments. The therapy aims to deliver radiation directly to the cancer cells, potentially reducing the size of the tumor or slowing its growth.

What is already known about the treatment

177Lu-DOTATATE – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its safety and effectiveness. It is primarily used for treating children with recurrent or refractory neuroblastoma, a type of cancer that affects nerve tissue. The drug works by targeting somatostatin receptors on cancer cells, delivering radiation directly to the tumor, which helps to destroy the cancerous cells. It belongs to the pharmacological class of peptide receptor radionuclide therapy (PRRT), which combines a targeting molecule with a radioactive component to treat specific types of cancer.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and develops from immature nerve cells found in several areas of the body. It often begins in the adrenal glands, which are located on top of the kidneys, but can also develop in the neck, chest, abdomen, or spine. The disease can be recurrent, meaning it returns after treatment, or refractory, meaning it does not respond to treatment. Neuroblastoma can spread to other parts of the body, such as the bones, bone marrow, and lymph nodes. Symptoms may include a lump in the abdomen, neck, or chest, bone pain, and a feeling of fullness in the abdomen. The progression of neuroblastoma can vary, with some cases being aggressive and others resolving spontaneously.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2024-515552-21-00Protocol code15TETE04Estimated enrolment18 patientsSponsorOncopole Claudius Regaud

sourced from the EU Clinical Trials Register and site verification

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