Study of drug combination therapy for high-risk medulloblastoma in patients over 3 years of age: carboplatin, cisplatin, cyclophosphamide, lomustine, temozolomide, thiotepa, vincristine

3 1 1 1

What is this study about?

This clinical trial focuses on treating high-risk medulloblastoma, which is a type of brain tumor. The study specifically targets patients who have either sonic hedgehog (SHH) subgroup or non-SHH/non-WNT (Groups 3 and 4) medulloblastoma with additional high-risk features. The treatment involves multiple medications including carboplatin, cisplatin, cyclophosphamide, lomustine, temozolomide, thiotepa, and vincristine sulfate.

The purpose of this study is to determine if treatment outcomes can be improved by using either specialized radiation therapy called hyperfractionated-accelerated radiotherapy or high-dose therapy with thiotepa, compared to standard radiation therapy. The study will also evaluate the effectiveness of different maintenance chemotherapy treatments.

The treatment plan combines various methods of drug administration, with some medications given through a vein (intravenous route) and others taken by mouth (oral route). The medications will be given according to specific schedules and doses determined by the study protocol. The study will track how well patients respond to treatment by measuring how long they remain free of disease progression and their overall survival.

1 Initial treatment phase

The treatment begins with induction chemotherapy, which includes carboplatin administered through an intravenous line

During this phase, regular blood tests will monitor your blood cell counts and organ function

2 Radiation therapy options

You will receive one of two types of radiation therapy:

Option 1: Conventional radiation therapy – once daily treatments

Option 2: Hyperfractionated-accelerated radiation therapy (HART) – multiple treatments per day

3 Medication administration

You will receive various medications through different methods:

Intravenous medications: carboplatin, cisplatin, cyclophosphamide, vincristine sulfate, and thiotepa

Oral medications: temozolomide and lomustine in capsule form

The specific schedule and doses will be provided by your medical team

4 High-dose therapy phase

Some patients will receive high-dose therapy with thiotepa

This treatment is given through an intravenous line

This phase is followed by conventional radiation therapy

5 Maintenance therapy

The final phase includes maintenance chemotherapy

Two different maintenance therapy options are available

Regular monitoring of your health status will continue throughout this phase

6 Ongoing monitoring

Regular assessments will track your response to treatment

Blood tests and imaging studies will be performed at scheduled intervals

Your hearing will be monitored throughout the treatment

Who Can Join the Study?

  • Age at diagnosis must be 3 years or older
  • Must have confirmed high-risk medulloblastoma (a type of brain tumor) that has been reviewed by specialists
  • Must be medically fit to receive treatment
  • Must have adequate:
    • Liver function (shown by specific blood test results)
    • Kidney function (shown by normal creatinine levels)
    • Blood cell counts (specifically neutrophils and platelets at required levels)
  • Must have good hearing in at least one ear
  • Must not have received any previous treatment for medulloblastoma except:
    • Surgery
    • One course of initial chemotherapy (if urgently needed)
  • Must provide biological samples including:
    • Tumor tissue samples
    • Blood samples
  • Must provide written informed consent (from patient and/or parent/legal guardian)
  • For women who can become pregnant:
    • Must have a negative pregnancy test
    • Must agree to use effective contraception during treatment

Who Cannot Join the Study?

  • Prior cancer treatment (chemotherapy, radiotherapy, or immunotherapy) before enrolling in this study, except for surgery to remove the tumor
  • History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart problems or unstable heart disease
  • Severe kidney or liver problems that could affect treatment
  • Active, uncontrolled infections requiring treatment
  • Known HIV (Human Immunodeficiency Virus) infection
  • Pregnancy or breastfeeding
  • Inability to undergo MRI (Magnetic Resonance Imaging) scans
  • Mental conditions that would prevent understanding or following study requirements
  • Known allergies to medications used in the study
  • Participation in another clinical trial within 30 days before starting this study
  • Any medical condition that the study doctor believes would make participation unsafe
  • Inability to follow up regularly for study visits and assessments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Varsinais-Suomen hyvinvointialue Turku Finland
Medizinische Universitaet Innsbruck Innsbruck Austria
University Medical Center Hamburg-Eppendorf Hamburg Germany
Universitaetsklinikum Essen AöR Essen Germany
IRCCS Istituto Giannina Gaslini Genoa Italy
Technische Universitaet Dresden Dresden Germany
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Oslo Universitetssykehus HF Oslo Norway
Universitair Ziekenhuis Gent Gent Belgium
Universitair Medisch Centrum Groningen Groningen The Netherlands
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Medizinische Hochschule Hannover Hanover Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Martin-Luther-Universitaet Halle-Wittenberg Halle (Saale) Germany
Universitaetsklinikum Augsburg Augsburg Germany
St. Olavs Hospital HF Trondheim Norway
Johannes Wesling Klinikum Minden Minden Germany
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Sana Kliniken Duisburg GmbH Duisburg Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Ancona Italy
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
Azienda Ospedaliera di Padova Padua Italy
University Hospital Cologne Cologne Germany
Fakultni nemocnice Motol a Homolka Prague Czechia
Odense University Hospital Odense Denmark
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Medical University Of Vienna Vienna Austria
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Universita’ Degli Studi Di Verona Verona Italy
Uppsala University Hospital Uppsala Sweden
Helse Bergen HF Bergen Norway
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Saarland University Hospital Homburg Germany
University Hospital Jena KöR Jena Germany
Helsinki University Central Hospital Helsinki Finland
University Medicine Greifswald Greifswald Germany
Aarhus University Hospital Aarhus Denmark
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino Turin Italy
Kliniken der Stadt Koeln gGmbH Cologne Germany
Universitaetsklinikum Muenster AöR Munster Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
CHC MontLegia Liege Belgium
Goethe University Frankfurt Frankfurt Germany
Medical University Of Graz Graz Austria
Klinikum der Universitaet Muenchen AöR Munich Germany
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
ARNAS G. Brotzu Cagliari Italy
Universitaet Leipzig Leipzig Germany
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Katholieke Universiteit te Leuven Leuven Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
University Childrens Hospital Queen Fabiola Brussels Belgium
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Uniklinikum Salzburg Salzburg Austria
Universitaetsklinikum Aachen AöR Aachen Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy

Other Sites

Site Name City Country Status
Gemeinschaftskrankenhaus Herdecke gGmbH Herdecke Germany
University Hospital Consorziale Policlinico Bari Italy
Universitätsklinikum Rostock Rostock Germany
Kxyxrmzs Deyitrac gavld Dortmund Germany
Hzwrgw Kapmndpe Kseftth Guxo Krefeld Germany
Sve Acjw Kotegqlsuwdr Gvpw Vienna Austria
Hgzaqc Kxxsxaah Enjqbu Grip Erfurt Germany
Gmtjypdgmb Nwqi gkcex Kevmvqgwikhvz Bcrgwt Bremen Germany
Kkmjhnmuj Tttcwsftxueswtygdxt Cunyasz mjp Cottbus Germany
Qynuc Sedbpp Cejmpebpmtjckpvu Hqrmzjqh Gothenburg Sweden
Hhehgr Kzorefuy Bfjketnoxty Gefr Berlin Germany
Gcjwanfjgefysdihtqucw Mcdxhdgkrbm gjpbp Koblenz Germany
Kaiuavxnyk Uqskoemdnt Hkjirxouv Wgsainciyb Stockholm Sweden
Ewgqvmzgfbtvj Keopfemc Bzdjim gkgdu Bielefeld Germany
Nmdkjsrng Uooajxuhmx Hsolgski Umea Sweden
Uhjvtwommcshyfypmhmcb Mvkjioyz Ghcm Mannheim Germany
Ksfkyryf Knsayt Gedr Kassel Germany
Utyzvlxfge Hsutqfnr Lund United Kingdom
Unekomdswewhnztljany Dgnrrmkryc Duesseldorf Germany
Ttd Kjpwjrga ujy Mwrscmf Kwstpz grnbr Munich Germany
Uofkalzhpwwr Zlecidmzew Awyundrtk (jzzl Edegem Belgium

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
31.01.2025
Belgium Belgium
Recruiting
31.01.2025
Czechia Czechia
Recruiting
31.01.2025
Denmark Denmark
Recruiting
31.01.2025
Finland Finland
Recruiting
31.01.2025
Germany Germany
Recruiting
31.01.2025
Italy Italy
Recruiting
31.01.2025
Norway Norway
Recruiting
31.01.2025
Sweden Sweden
Recruiting
31.01.2025
The Netherlands The Netherlands
Recruiting
31.01.2025

Trial locations

Thiotepa is a chemotherapy medication used in high-dose therapy for treating medulloblastoma, a type of brain tumor. It works by interfering with cancer cell DNA, helping to stop tumor growth.

Radiotherapy is a treatment that uses high-energy radiation beams to target and destroy cancer cells. The trial compares two different approaches to radiation therapy:
– Conventional radiotherapy, which delivers radiation once per day
– Hyperfractionated-accelerated radiotherapy (HART), which delivers radiation multiple times per day in smaller doses

The trial also includes maintenance chemotherapy, which is long-term treatment given after the main treatment to help prevent the cancer from returning. Two different maintenance chemotherapy approaches are being compared in this study.

Medulloblastoma – A rare type of brain tumor that starts in the lower back part of the brain called the cerebellum. It begins when brain cells have changes in their DNA, causing cells to grow and divide uncontrollably. The disease can occur in different subtypes, including sonic hedgehog (SHH) and Groups 3 and 4 variants. Medulloblastoma tends to spread through the cerebrospinal fluid that surrounds and protects the brain and spinal cord. The condition can affect both children and adults, though it’s more commonly found in children.

Trial ID:
2024-510578-25-00
Protocol code:
RG_18-205
Trial Phase:
Therapeutic confirmatory (Phase III)

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