Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of Temozolomide, Topotecan, Bevacizumab, Irinotecan and Dinutuximab Beta in Patients with High-Risk Relapsed Neuroblastoma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on treating high-risk relapsed neuroblastoma, a type of cancer that has returned after initial treatment or has progressed after being classified as high-risk at any point following diagnosis. The study aims to test new treatments against currently available options for patients whose cancer has returned. The trial will evaluate several medications including temozolomide, topotecan, bevacizumab, dinutuximab beta, and irinotecan.

The study is designed as a platform trial with multiple treatment arms, meaning different treatment combinations will be tested simultaneously. Some medications will be given by mouth, while others will be administered through an intravenous line (directly into the vein). The treatments will be given in cycles, and patients will be monitored for up to 12 treatment cycles.

During the study, doctors will track how well the treatments work by measuring if the cancer stops growing or shrinks, how long patients live without their disease getting worse, and how long they survive overall. They will also monitor side effects and assess quality of life using questionnaires. Patients will have regular medical examinations, including scans and blood tests, to evaluate their response to treatment.

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 medical assessment

    Your doctor will perform medical tests to confirm neuroblastoma diagnosis and evaluate your eligibility for the study

    Blood tests will check your liver function, blood count, and kidney function

    Blood pressure measurement must be performed

    Your overall physical condition will be assessed using a performance status scale

  2. Step 2

    Treatment assignment

    Based on your medical history, you will be assigned to one of two treatment tiers

    If this is your first relapse, you may be eligible for Tier 1

    If you have had more than one relapse, you will be assigned to Tier 2

  3. Step 3

    Treatment administration

    You will receive a combination of medications that may include:

    Temozolomide - taken by mouth

    Topotecan - given through an intravenous (IV) line

    Dinutuximab beta - given through an IV line

    Bevacizumab - given through an IV line

    Irinotecan - given through an IV line

    The treatment will continue for up to 12 cycles

  4. Step 4

    Regular monitoring

    Your disease will be monitored regularly using imaging scans

    Blood tests will be performed to check your health status

    Side effects will be monitored and recorded

    Quality of life assessments will be conducted using questionnaires

  5. Step 5

    Treatment completion

    The study will evaluate how long you remain free from disease progression

    Your overall survival will be monitored

    The effectiveness of the treatment will be assessed based on your response to therapy

    Follow-up assessments will continue after treatment completion

Who can join the trial?

12 criteria

  • Age must be 1 year or older
  • Must have confirmed high-risk neuroblastoma that has returned or gotten worse after previous treatment
  • Disease must be measurable through imaging scans or special tests (called MIBG scan). Disease detected only in bone marrow is not eligible
  • Must have adequate physical function with a performance score of at least 50% (ability to perform daily activities)
  • Expected survival time of at least 12 weeks
  • Must have adequate blood test results: - Blood platelets at least 50,000 per microliter without transfusions - White blood cells (neutrophils) at least 500 per microliter without medication support - Hemoglobin above 8 g/dL (blood transfusions allowed)
  • Liver function must be within acceptable limits (blood tests required within 72 hours before starting)
  • Kidney function must be within acceptable limits (tests required within 72 hours before starting)
  • Blood pressure must be below the 95th percentile for age and sex. For adults (18+ years), blood pressure must be below 150/90 mmHg
  • Must not have uncontrolled blood clotting problems (patients on blood thinners are allowed if stable)
  • Must have experienced more than one relapse or be ineligible for Tier 1 treatment
  • Written informed consent must be provided by the patient, parent, or guardian

Who cannot join the trial?

12 criteria

  • Previous participation in any other clinical trial within 30 days before starting this study
  • Having any serious medical conditions that could interfere with study participation, including:
    • Severe heart problems
    • Serious liver dysfunction
    • Severe kidney problems
    • Known allergic reactions to similar medications
    • Current pregnancy or breastfeeding
    • Inability to follow study procedures
    • Having received other cancer treatments within the last 4 weeks
    • Active, uncontrolled infections requiring treatment
    • Major surgery within 4 weeks before starting the study
    • Presence of any condition that the study doctor believes would make participation unsafe
    • Mental conditions that could affect the ability to provide informed consent or follow study instructions
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Since the provided source data does not contain specific information about medications or therapies used in the trial, I cannot provide a detailed list of medications. The data only shows that this is a platform trial called BEACON 2 for relapsed neuroblastoma, which is designed to test novel treatments against current best available treatment, but the specific medications are not listed in the source data. To properly list and describe medications, I would need information about the specific drugs or therapies being tested in this neuroblastoma trial.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions. The data only shows that this is a clinical trial (BEACON 2) focused on testing novel treatments for relapsed neuroblastoma, but doesn't specify which medications are being studied. If you provide information about specific medications involved in this trial, I can create descriptions following the requested format.

Investigated diseases

Neuroblastoma - A rare type of cancer that develops from immature nerve cells, typically starting in the adrenal glands but can develop in other areas of the body. The disease most commonly occurs in children under the age of 5 years. Neuroblastoma can start in different places along the sympathetic nervous system, which controls body functions like heart rate, blood pressure, and digestion. The cancer cells can form solid tumors that grow and spread to other parts of the body, including bone marrow, bones, lymph nodes, liver, and skin. High-risk neuroblastoma refers to cases where the cancer has unfavorable biological features or has spread widely in the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516115-24-00Protocol codeRG_22-136Estimated enrolment154 patientsSponsorThe University Of Birmingham

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.