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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Des Enfants Toulouse France
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
St. Anna Kinderspital GmbH Vienna Austria
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario De Cruces Barakaldo Spain
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
University Childrens Hospital Queen Fabiola Brussels Belgium
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Uniklinikum Salzburg Salzburg Austria
Ludwig Maximilian Universität München Munich Germany
Universitätsklinikum Köln Klinik und Poliklinik für Kinder- und Jugendmedizin Pädiatrische Onkologie Cologne Germany
Universitätsklinikum Hamburg-Eppendorf Poliklinik für Pädiatrische Hämatologie und Onkologie Hamburg Germany
Czpjjbthr Urvuqwofhakytg Scucurmyo Woluwe-Saint-Lambert Belgium
Cxtfwe Lete Bozpmf Lyon France
Pctyuodg Milczv Cfxnmj Uypbaoe Utrecht The Netherlands
Kdjtjpjajc Uzowxmovpw Hrmyzjlsj Wtgnwsxtlh Stockholm Sweden
Amlwbviovm Phxqyvwb Hvbuocgd Dq Muzgngnpn Marseille France
Akwcaed Ogxybhmlvos Uupygiybwloub Cesqoonnufvm Diqil Suisqo E Dqumo Spumuds Dd Tqbunk Turin Italy
Ufqrjaaifprirnnlrfplu Mmyxdpdd Apa Munster Germany
Cvyj Dl Ngkkp Vandoeuvre Les Nancy France
Ubjvyfynwi Oy Axwiuqa Edegem Belgium
Ugnmfxazhpjlejhljktrs Ekkms Alo Essen Germany
Usfxdmxtgeilcnvmrvinc Ajgrmsvl Augsburg Germany
Fvqcdzopt Pzkc Lp Igueigmlmzzhd Blqcehzoz Dgl Hkdxmxtt Uylnknzvvycfk Lp Pou Madrid Spain
Jpiozvfc Kzbjek Umrxocqikp Linz Austria
Hvpagfgt Vyzq dxjgfxvk Barcelona Spain
Chuafy Oqkmt Lzfimjy Lille France
Hjdqnyoe Ugwapqevzeczhv Slzpmotolv &hylhwh Hxnkake ds Hduhitcpmzu STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.06.2025
Belgium Belgium
Not yet recruiting
01.06.2025
Denmark Denmark
Not yet recruiting
01.06.2025
France France
Not yet recruiting
01.06.2025
Germany Germany
Not yet recruiting
01.06.2025
Italy Italy
Not yet recruiting
01.06.2025
Norway Norway
Not yet recruiting
01.06.2025
Spain Spain
Not yet recruiting
01.06.2025
Sweden Sweden
Not yet recruiting
01.06.2025
The Netherlands The Netherlands
Not yet recruiting
01.06.2025

Trial locations

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.

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 ID:
2024-516115-24-00
Protocol code:
RG_22-136
NCT ID:
NCT07334301
Trial Phase:
Human Pharmacology (Phase I) – Other

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