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Study on Dinutuximab Beta with Chemotherapy for Children and Teens with Newly Diagnosed High-Risk Neuroblastoma

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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 type of cancer called neuroblastoma, which is a cancer that most commonly affects children. The study is testing a treatment that combines a medication called dinutuximab beta with other chemotherapy drugs. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The chemotherapy drugs being used in this study include dacarbazine, etoposide, cisplatin, vincristine sulfate, ifosfamide, carboplatin, doxorubicin hydrochloride, and cyclophosphamide. These drugs are given to patients to see how well they work together with dinutuximab beta in treating newly diagnosed high-risk neuroblastoma.

The purpose of the study is to find out how safe and tolerable the combination of dinutuximab beta and chemotherapy is for patients, and to determine the best dose to use. Patients in the study will receive the treatment in cycles, which means they will have periods of receiving the medication followed by periods of rest. The study will monitor patients for any side effects and how their cancer responds to the treatment. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study will take place over several years, with patients being closely monitored throughout the process. The goal is to gather information on the safety and effectiveness of the treatment combination, which could lead to better treatment options for children with high-risk neuroblastoma in the future. Participants will be required to attend regular follow-up appointments to track their progress and any changes in their condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. Consent will be obtained from the patient or their legal representative.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of neuroblastoma and ensuring the patient meets age and health criteria.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of dinutuximab beta combined with chemotherapy regimens. The specific regimen will be determined based on the patient's condition.

    Chemotherapy drugs may include dacarbazine, etoposide, cisplatin, vincristine sulfate, ifosfamide, carboplatin, doxorubicin hydrochloride, and cyclophosphamide. These are administered as solutions for infusion or injection.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, the patient will be closely monitored for any side effects or adverse reactions. Regular evaluations will assess the effectiveness of the treatment and the patient's response.

  5. Step 5

    Follow-up

    After completing the treatment phase, the patient will have scheduled follow-up visits to monitor long-term health and any potential late effects of the treatment.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of neuroblastoma Stage M, which is a type of cancer that affects nerve tissue, according to specific medical criteria.
  • Must be at least 18 months old and younger than 18 years old.
  • Must weigh more than 12 kilograms.
  • Must have certain liver function tests within specific limits: Alanine transaminase (ALT) and aspartate aminotransferase (AST)total bilirubin should be less than 1.5 times the normal upper limit, based on age-specific ranges.
  • Must have a kidney function test result, called glomerular filtration rate, greater than 60 mL/min/1.73 m², or a serum creatinine level less than 1.5 times the normal upper limit, adjusted for age.
  • Must have a heart function test result, called shortening fraction (SF), of at least 27% and/or a left ventricular ejection fraction (LVEF) greater than 50%, as determined by heart imaging tests.
  • Must be able to attend scheduled follow-up visits and participate in study procedures.
  • Must have written consent from parents or legal representatives, and agreement from the patient if they are old enough, before any study-specific screening procedures are done, following local laws.

Who cannot join the trial?

9 criteria

  • Patients who are not diagnosed with **neuroblastoma**. Neuroblastoma is a type of cancer that usually affects young children.
  • Patients who are not considered high-risk according to specific medical guidelines.
  • Patients who are younger than 18 months or older than 18 years.
  • Patients who are not able to safely receive the study treatments due to other health conditions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who have certain infections or diseases that could interfere with the study.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

  • Dinutuximab beta

    is a medication used in this trial to treat high-risk neuroblastoma, a type of cancer that occurs in certain types of nerve tissue. It is being tested to see how safe and tolerable it is when combined with other chemotherapy treatments. The goal is to find the best dose that can be used safely with these treatments.

  • Induction chemotherapy regimens (GPOH or rapid COJEC)

    are combinations of chemotherapy drugs used to shrink tumors and kill cancer cells in patients with high-risk neuroblastoma. These regimens are part of the initial treatment phase and are being tested in combination with dinutuximab beta to see if they work better together.

What is already known about the treatment

Dinutuximab beta – This medication is administered intravenously and is currently being studied in clinical trials for its use in treating high-risk neuroblastoma, a type of cancer that occurs in children. It is in the investigational stage, with ongoing research to determine its safety and optimal dosage when combined with chemotherapy. Dinutuximab beta is primarily indicated for neuroblastoma and works by targeting a specific molecule on cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children, particularly those under the age of five. It originates in immature nerve cells, often starting in the adrenal glands located above the kidneys, but it can also develop in the neck, chest, abdomen, or spine. The disease can spread to other parts of the body, including the bones, bone marrow, and lymph nodes. Symptoms may vary depending on the location of the tumor and can include abdominal pain, a lump in the abdomen, or changes in bowel habits. As the disease progresses, it may cause fatigue, loss of appetite, and weight loss. Neuroblastoma is considered a high-risk cancer when diagnosed in older children or when it has spread extensively.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2023-509673-22-00Protocol codeSIOPEN-Pilot01Estimated enrolment39 patientsSponsorPrincess Maxima Center For Pediatric Oncology

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).