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

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 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.

The research process

The trial runs in 6 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 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Based on the provided clinical trial data, since there is only one specific medication mentioned: Thiotepa - A chemotherapeutic agent administered as high-dose therapy (HDT) that belongs to the alkylating agents class of medications. It is used in the treatment of high-risk medulloblastoma, particularly in combination with conventional radiotherapy as part of an intensive treatment protocol. Thiotepa works by interfering with DNA replication in cancer cells, preventing them from dividing and ultimately leading to their death, and it is typically administered intravenously under careful medical supervision in specialized oncology centers. Note: The trial data mentions conventional radiotherapy and hyperfractionated-accelerated radiotherapy (HART), but these are treatment modalities rather than medications, so they are not included in the medication description format.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510578-25-00Protocol codeRG_18-205Estimated enrolment650 patientsSponsorThe University Of Birmingham

sourced from the EU Clinical Trials Register and site verification

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