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Study on Radiotherapy with Nimotuzumab and Vinorelbine for Newly Diagnosed Childhood and Adolescent Diffuse Intrinsic Pontine Glioma (DIPG) Patients

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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 brain tumor called Diffuse Intrinsic Pontine Glioma (DIPG), which primarily affects children and adolescents. The study involves two treatments: nimotuzumab, a monoclonal antibody, and vinorelbine tartrate, a chemotherapy drug. These treatments are given alongside radiotherapy, which uses high-energy rays to target and kill cancer cells. The purpose of the study is to compare the effectiveness of different radiotherapy approaches when used with these medications.

Participants in the study will receive either a combination of radiotherapy, nimotuzumab, and vinorelbine, or a series of radiotherapy sessions with the same medications. The study will observe how well the tumor responds to these treatments over a period of 36 weeks. The goal is to determine which approach provides the best response in shrinking or controlling the tumor.

The study will also monitor other important outcomes, such as the time until the disease progresses, any recurrence of the tumor, the development of any new cancers, and overall survival. This information will help researchers understand the potential benefits and risks of using nimotuzumab and vinorelbine in treating DIPG, and may guide future treatment options for this challenging 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

    Initial assessment

    Eligibility is determined based on age (2 to 21 years), absence of previous treatments except for steroids, and specific medical criteria related to the condition known as diffuse intrinsic pontine glioma (DIPG).

    A baseline cranial MRI with gadolinium is required, and a spinal MRI is mandatory due to the possibility of metastatic cases at diagnosis.

  2. Step 2

    Treatment initiation

    The treatment involves radiotherapy combined with two medications: nimotuzumab and vinorelbine tartrate. Both medications are administered as a solution for infusion through an intravenous route.

    The study compares two approaches: conventional irradiation and experimental irradiation, with the primary aim of evaluating the best response up to 36 weeks.

  3. Step 3

    Medication administration

    Nimotuzumab and vinorelbine tartrate are administered concomitantly with radiotherapy. The specific dosage and frequency are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment, including complete and partial responses up to week 36.

    Secondary outcomes such as disease progression, recurrence, secondary malignancy, and survival are also evaluated.

  5. Step 5

    Re-irradiation at relapse

    In cases of relapse, re-irradiation may be considered as part of the treatment plan, depending on the study arm and individual patient circumstances.

Who can join the trial?

11 criteria

  • Patients must be between 2 and 21 years old.
  • No previous treatments are allowed, except for the use of steroids.
  • Patients must have a specific type of brain tumor called Diffuse Intrinsic Pontine Glioma (DIPG). This is a tumor located in a part of the brain called the pons, and it must show certain characteristics on MRI scans.
  • Symptoms of the condition must have been present for less than 6 months.
  • Patients must have a life expectancy of at least 4 weeks.
  • The Karnofsky/Lansky performance status must be 40% or higher. This is a scale that measures the patient's ability to perform daily activities.
  • Patients must not have any organ dysfunction.
  • Patients must not be pregnant or breastfeeding.
  • A baseline MRI scan of the brain with a contrast agent called gadolinium is required. If treatment starts more than 2 weeks after this scan, it must be repeated. An MRI of the spine is also required to check for any spread of the disease.
  • Written and signed informed consent must be obtained from the patient's parents or legal guardians before starting treatment.
  • For patients in the observational group with a type of tumor called diffuse midline glioma, the diagnosis must be confirmed by a central review according to standard procedures in Italy.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of brain tumor than Diffuse Intrinsic Pontine Glioma cannot participate. This is a specific type of brain tumor that occurs in a part of the brain called the pons.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
  • Patients who are currently participating in another clinical trial cannot participate, as this might affect the results of the study.
  • Patients who have had certain treatments recently that might interfere with the study cannot participate.
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Investigated drugs

  • Nimotuzumab

    is a medication used in this trial to help treat a type of brain tumor called diffuse intrinsic pontine glioma (DIPG) in children and adolescents. It is a type of therapy that targets specific proteins on cancer cells, which may help slow down or stop the growth of the tumor.

  • Vinorelbine

    is another medication used in the trial. It is a type of chemotherapy that works by interfering with the growth of cancer cells, which can help to shrink the tumor or slow its growth.

  • Radiotherapy

    is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, radiotherapy is used in combination with the medications to enhance their effectiveness against the tumor.

  • Re-irradiation

    is a process where radiotherapy is given again after the initial treatment, especially if the cancer returns or relapses. This approach is being studied to see if it can improve outcomes for patients with DIPG.

What is already known about the treatment

  • Nimotuzumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating diffuse intrinsic pontine glioma, a type of brain tumor. Nimotuzumab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which is often overexpressed in certain cancers. By binding to EGFR, it inhibits the growth and survival of cancer cells. It is classified as an antineoplastic agent, specifically a monoclonal antibody.

  • Vinorelbine

    This medication is given orally or intravenously and is also under investigation in clinical trials for diffuse intrinsic pontine glioma. Vinorelbine works by interfering with the formation of microtubules, which are essential for cell division, thereby inhibiting the growth of cancer cells. It belongs to the class of medications known as vinca alkaloids, which are used in cancer treatment.

Investigated diseases

Diffuse Intrinsic Pontine Glioma – This is a rare and aggressive brain tumor that primarily affects children. It occurs in the pons, a part of the brainstem, which controls essential functions such as breathing and heart rate. The tumor grows rapidly and infiltrates the surrounding brain tissue, making it difficult to treat. Symptoms often include problems with balance and coordination, difficulty swallowing, and facial weakness. As the disease progresses, these symptoms can worsen, leading to more severe neurological impairments. The condition is challenging to manage due to its location and aggressive nature.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513654-30-00Protocol codeDIPGEstimated enrolment81 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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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).