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Study on Bevacizumab with Temozolomide and Irinotecan for Children with Relapsed or Refractory 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 treatments for Neuroblastoma, a type of cancer that most commonly affects children. The study will explore the effectiveness of adding Bevacizumab to a chemotherapy regimen that includes Temozolomide, with or without Irinotecan, and also the combination of Topotecan with Temozolomide. Bevacizumab is a medication that can help prevent the growth of blood vessels that feed tumors, while Temozolomide, Irinotecan, and Topotecan are chemotherapy drugs that work by killing cancer cells or stopping them from growing.

The purpose of the study is to determine if these combinations can improve treatment outcomes for children whose neuroblastoma has returned or has not responded to previous treatments. Participants in the study will receive one of these treatment combinations, or a placebo, over a period of up to 24 months. The study will monitor the participants' response to the treatment, including any changes in the size of the tumor and the overall health of the participants.

Throughout the study, the safety of the treatments will be closely monitored, and any side effects will be recorded. The study aims to provide valuable information on whether these treatment combinations can offer better outcomes for children with relapsed or refractory neuroblastoma, potentially leading to improved treatment options in the future.

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 treatment phase

    The treatment begins with the administration of temozolomide orally. This medication is taken to help manage the condition.

    Following the oral administration of temozolomide, dinutuximab beta is given through an intravenous route. This involves receiving the medication directly into the bloodstream via a vein.

  2. Step 2

    Combination therapy phase

    The next phase involves a combination of medications. Temozolomide is administered orally again.

    In addition to temozolomide, irinotecan is given intravenously. This combination aims to enhance the treatment's effectiveness.

  3. Step 3

    Additional treatment phase

    The treatment continues with another cycle of temozolomide taken orally.

    Following this, bevacizumab is administered intravenously. This medication is added to support the overall treatment plan.

  4. Step 4

    Further combination therapy

    The patient receives temozolomide orally once more.

    This is followed by an intravenous administration of cyclophosphamide, which is intended to work in conjunction with temozolomide.

  5. Step 5

    Final treatment phase

    The final phase involves taking temozolomide orally.

    The treatment concludes with an intravenous administration of topotecan, which is designed to maximize the treatment's potential benefits.

Who can join the trial?

14 criteria

  • The patient must have a confirmed diagnosis of **neuroblastoma**, which is a type of cancer.
  • The patient must have **relapsed** or **refractory** neuroblastoma, meaning the cancer has returned or did not respond to initial treatment.
  • The patient must be between the ages of **1 and 21 years**.
  • The patient must have a **measurable disease**, which means the cancer can be seen on scans or tests.
  • The patient must have a **performance status** that allows them to be active, even if they need help, such as being able to sit up in a wheelchair.
  • The patient must have **adequate heart function**, shown by a test called an echocardiogram.
  • The patient must have **adequate lung function**, meaning they can breathe well without help.
  • The patient must have **adequate bone marrow function**, which means their blood counts are at a safe level.
  • The patient must have **adequate kidney function**, shown by a test that measures how well the kidneys are working.
  • The patient must have **adequate liver function**, meaning their liver is working well enough.
  • Females who can have children must have a **negative pregnancy test** before starting treatment and agree to use birth control during the study and for 6 months after.
  • Males must agree to use a **condom** during the study and for 6 months after the last treatment.
  • The patient must be willing to have a **central venous access**, which is a special type of IV line, if needed for treatment.
  • The patient or their guardian must give **informed consent**, meaning they understand and agree to participate in the study.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than neuroblastoma cannot participate. Neuroblastoma is a type of cancer that usually affects young children and develops from nerve cells.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for a specific age group.
  • Patients who are not able to follow the study procedures or take the required medications 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 medications that could affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
  • Patients who have allergies or adverse reactions to the study medications cannot participate.
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Investigated drugs

  • Bevacizumab

    is a medication used in this trial to see if it can improve the effectiveness of chemotherapy in children with neuroblastoma that has come back or is not responding to treatment. It works by blocking a protein that helps cancer cells grow new blood vessels, which can slow down or stop the growth of the cancer.

  • Temozolomide

    is a chemotherapy drug used in this trial as part of the treatment for children with neuroblastoma. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing.

  • Irinotecan

    is another chemotherapy drug being tested in combination with temozolomide in this trial. It works by interfering with the DNA of cancer cells, preventing them from multiplying. The trial aims to see if adding irinotecan to temozolomide makes the treatment more effective.

  • Topotecan

    is also a chemotherapy drug included in this trial. It is being tested to determine if its addition to temozolomide can enhance the treatment's effectiveness against neuroblastoma. Like irinotecan, topotecan works by disrupting the DNA of cancer cells, which can help stop their growth.

What is already known about the treatment

  • Bevacizumab

    Bevacizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating neuroblastoma, a type of cancer that occurs in children. It is primarily used to inhibit the growth of blood vessels that supply tumors, thereby slowing or stopping tumor growth. Bevacizumab works by targeting and blocking a protein called vascular endothelial growth factor (VEGF), which is essential for the formation of new blood vessels. It is classified as an angiogenesis inhibitor.

  • Temozolomide

    Temozolomide is taken orally in capsule form and is being evaluated in clinical trials for its potential to treat neuroblastoma in children. It is commonly used as a chemotherapy agent to treat certain types of brain tumors. Temozolomide works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent.

  • Irinotecan

    Irinotecan is administered intravenously and is under investigation in clinical trials for its role in treating neuroblastoma in children. It is typically used to treat colorectal cancer and works by interfering with the DNA replication process in cancer cells, leading to cell death. Irinotecan is classified as a topoisomerase inhibitor.

  • Topotecan

    Topotecan is given intravenously and is being studied in clinical trials for its effectiveness in treating neuroblastoma in children. It is used to treat certain types of cancer, including ovarian and small cell lung cancer. Topotecan works by inhibiting the enzyme topoisomerase I, which is necessary for DNA replication, thereby preventing cancer cell growth. It is classified as a topoisomerase inhibitor.

Investigated diseases

Neuroblastoma – Neuroblastoma is a type of cancer that most commonly affects children and arises from immature nerve cells found in several areas of the body. It typically 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 spread to other parts of the body, including lymph nodes, bones, bone marrow, liver, and skin. 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 known for its ability to spontaneously regress in some cases, but it can also be aggressive and challenging to treat.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2024-518931-12-00Protocol codeRG_11-087Estimated enrolment211 patientsSponsorThe University Of Birmingham

sourced from the EU Clinical Trials Register and site verification

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