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Study on Dinutuximab Beta and Drug Combination for Children, Teens, and Adults with GD2-Positive Ewing Sarcoma

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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 Ewing Sarcoma, which can affect bones or soft tissues. The study involves a combination of medications to find the best dose for treating this cancer. The medications being tested include dinutuximab beta, vincristine sulfate, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. These drugs are given through a vein, which is known as intravenous use. The purpose of the study is to determine the most effective dose of dinutuximab beta when used with these other medications.

Participants in the study will receive these medications in a specific order and combination. The study will monitor how well the treatment works and how safe it is for patients. The researchers aim to find the dose that provides the best balance between effectiveness and safety. This process is known as dose escalation, where doses are gradually increased to find the optimal level. The study will also look at how long patients remain free from cancer progression and how long the treatment response lasts.

The trial is open to children, adolescents, and adults with a specific type of Ewing Sarcoma that tests positive for a marker called GD2. The study will help determine the recommended dose for future research and treatment plans. The trial is expected to continue until 2027, with recruitment starting in 2025. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the treatment's effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    The treatment begins with the administration of a combination of medications designed to target Ewing sarcoma. These medications include doxorubicin, dinutuximab beta, ifosfamide, mesna, etoposide, cyclophosphamide, and vincristine sulfate. All these medications are given through a vein (intravenous use).

    The treatment is structured in cycles, starting with a standard induction treatment consisting of four cycles: VDC (vincristine, doxorubicin, cyclophosphamide) followed by IE (ifosfamide, etoposide), then repeated.

  2. Step 2

    Administration of filgrastim

    Filgrastim is administered by injection to help the body produce more white blood cells, which can be reduced by chemotherapy. This helps to reduce the risk of infection during the treatment.

  3. Step 3

    Dose escalation

    The primary goal of this phase is to determine the recommended dose of dinutuximab beta when used in combination with the other medications. This involves gradually increasing the dose to find the optimal level that maximizes effectiveness while minimizing side effects.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes evaluating any side effects and adjusting doses as necessary.

    The primary endpoint is to identify the recommended dose based on the evaluation of dose-limiting toxicities, overall safety, and tolerability.

  5. Step 5

    Progression-free survival assessment

    Progression-Free Survival (PFS) is measured from the start of treatment until the first sign of disease progression or death from any cause.

  6. Step 6

    Event-free survival assessment

    Event-Free Survival (EFS) is tracked from the beginning of treatment to any treatment-related event, such as disease progression, relapse, a second malignancy, or death.

  7. Step 7

    Duration of response evaluation

    The Duration of Response (DOR) is the time from the first documentation of a complete or partial response to the treatment until the disease progresses or relapses.

Who can join the trial?

16 criteria

  • Must have a confirmed diagnosis of **Ewing Sarcoma** or a similar type of cancer called **Ewing-like sarcoma**. This means the cancer has specific genetic changes that can be detected by special tests.
  • Must have a sample of the tumor available for testing.
  • Must be at least 12 months old.
  • Must have started the first line of standard treatment, which includes specific chemotherapy cycles.
  • Must have a break of at least 14 days after the last chemotherapy dose before starting the trial.
  • Must have a performance score indicating they are well enough to participate. For those under 16, a **Lansky score** of 70% or higher is needed. For those 16 and older, an **ECOG score** of 2 or less is required.
  • Must have adequate **bone marrow function**, meaning enough healthy blood cells are present. This includes a white blood cell count over 2000, an **ANC** (a type of white blood cell) of at least 1000, a platelet count of 75,000 or more, and a hemoglobin level of at least 9 g/dL.
  • Must have adequate **kidney function**, shown by a creatinine clearance or **GFR** greater than 60.
  • Must have adequate **liver function**, with specific levels of bilirubin, **AST**, and **ALT** within acceptable limits.
  • Must have adequate **heart function**, confirmed by a test showing a **left ventricular ejection fraction** of 50% or more.
  • Must not have active infections like **HIV**, **HBV**, or **HCV**.
  • Must not have severe neurological problems, except those caused by Ewing sarcoma.
  • Female patients who can have children must have a negative pregnancy test and agree to use birth control during the study and for 3 months after. If breastfeeding, they must stop from the start of the study until 1 month after treatment ends.
  • Must be willing and able to follow the study's requirements.
  • Must be classified as high risk, meaning the disease has spread to other parts of the body.
  • Must have a tumor that tests positive for **GD2**, a specific marker found in some cancers.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than Ewing Sarcoma cannot participate. Ewing Sarcoma is a type of cancer that occurs in bones or the soft tissue around the bones.
  • Patients who are not within the specified age range for the trial cannot participate. The trial is open to certain age groups only.
  • Patients who are not able to follow the trial procedures or take the trial medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the trial 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 to the trial medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the trial terms, cannot participate.
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Investigated drugs

  • Dinutuximab beta

    is a medication used in this trial to treat patients with GD2-positive Ewing sarcoma. It is an antibody that targets cancer cells, helping the immune system to recognize and destroy them. The trial aims to find the best dose of this medication when used with other cancer treatments.

  • Vincristine

    is a chemotherapy drug that works by stopping the growth of cancer cells. It is used in combination with other medications in this trial to enhance the treatment's effectiveness against Ewing sarcoma.

  • Doxorubicin

    is another chemotherapy medication included in the trial. It works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. This drug is part of the combination therapy being tested.

  • Cyclophosphamide

    is a chemotherapy drug that helps to kill or slow the growth of cancer cells. It is used in this trial as part of a combination treatment to improve outcomes for patients with Ewing sarcoma.

  • Ifosfamide

    is a chemotherapy medication that is used to treat various types of cancer, including Ewing sarcoma. It works by damaging the DNA of cancer cells, which stops them from multiplying.

  • Etoposide

    is a chemotherapy drug that helps to prevent cancer cells from dividing and growing. It is used in combination with other medications in this trial to treat patients with Ewing sarcoma.

What is already known about the treatment

Dinutuximab Beta – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Ewing Sarcoma, a type of cancer. It is not yet widely used in standard medical practice but is being explored for its potential benefits. Dinutuximab beta works by targeting GD2, a molecule found on the surface of certain 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

Ewing Sarcoma – Ewing Sarcoma is a type of cancer that typically occurs in bones or the soft tissue around the bones. It is most commonly found in children and young adults. The disease often begins in the long bones of the arms and legs, pelvis, or chest, but it can also occur in other bones or soft tissues. As it progresses, Ewing Sarcoma can cause pain and swelling in the affected area. It may also lead to fever, fatigue, and weight loss. The cancer can spread to other parts of the body, such as the lungs or other bones, if not addressed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515245-42-00Protocol codeCESS-GD2Estimated enrolment18 patientsSponsorGPOH gGmbH

sourced from the EU Clinical Trials Register and site verification

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