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Study on the Effects of Doxorubicin and Temozolomide After Radiotherapy in Children and Young Adults with Glioblastoma

Registered 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 the effects of a treatment for glioblastoma, a type of brain cancer. The treatment involves the use of two medications: doxorubicin hydrochloride and temozolomide. The study aims to evaluate the safety and tolerability of using doxorubicin in combination with radiotherapy and temozolomide in children and young adults who have been diagnosed with glioblastoma.

Participants in the study will receive doxorubicin through an intravenous infusion, which means it will be administered directly into a vein. Temozolomide will be taken orally, meaning it is swallowed in pill form. The study will observe how well patients tolerate this combination of treatments after they have undergone radiotherapy, which is a type of cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

The purpose of the study is to gather information on how safe and effective this treatment approach is for young patients with glioblastoma. The study will monitor participants over a period of time to see how they respond to the treatment and to identify any side effects that may occur. This information will help doctors understand if this combination of treatments can be a viable option for treating glioblastoma in pediatric and young adult patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the clinical trial, eligibility is confirmed based on specific criteria such as age, diagnosis, and health status.

    Written informed consent is required from the patient or their legal guardians.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's current health status and establish baseline measurements.

    This includes blood tests and imaging studies to assess the condition of the glioblastoma.

  3. Step 3

    Radiotherapy

    The patient undergoes a course of radiotherapy to target the glioblastoma.

    This phase is crucial for preparing the body for subsequent chemotherapy treatment.

  4. Step 4

    Chemotherapy with doxorubicin

    Following radiotherapy, the patient receives doxorubicin through an intravenous route.

    The dosage and frequency are determined by the medical team based on individual patient needs and response.

  5. Step 5

    Chemotherapy with temozolomide

    In addition to doxorubicin, temozolomide is administered orally.

    The combination of these medications aims to enhance the treatment's effectiveness against glioblastoma.

  6. Step 6

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to treatment and manage any side effects.

    This includes routine blood tests, imaging studies, and clinical evaluations.

  7. Step 7

    Completion and evaluation

    Upon completion of the treatment regimen, a final evaluation is performed to determine the overall response to the therapy.

    The patient's health status and any changes in the glioblastoma are thoroughly assessed.

Who can join the trial?

12 criteria

  • Patients must have a specific type of brain tumor called glioblastoma or related types, as classified by the World Health Organization (WHO) in 2016. This includes several subtypes like giant cell glioblastoma, gliosarcoma, and others.
  • Both males and females between the ages of 3 and 30 can participate.
  • Patients should have a life expectancy of at least 12 months.
  • Patients need to have a Karnofsky/Lansky score of 80% or higher. This score measures the patient's ability to carry out daily activities.
  • Patients must have adequate blood health, which means:
    • A white blood cell count of at least 2.0 x 109 per liter.
    • Hemoglobin levels of at least 10 grams per deciliter.
    • A platelet count of at least 50 x 109 per liter.
    • Patients need to have proper liver function, which means:
      • Total bilirubin levels should be no more than 2.5 times the upper limit of normal (ULN).
      • ALT/AST levels should be no more than 5 times the ULN. These are enzymes that help assess liver health.
      • Patients must have adequate kidney function, meaning serum creatinine levels should be no more than 1.5 times the ULN. Creatinine is a waste product that helps assess kidney health.
      • Written informed consent must be obtained from the patient, or their parents or legal guardians if the patient is a minor.
      • Patients must be available during the treatment period and able to follow the study's guidelines.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of brain tumor other than glioblastoma cannot participate. Glioblastoma is a specific type of brain cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study is for children and young adults.
  • Patients who are not able to safely receive the study treatments, which include doxorubicin, radiotherapy, and temozolomide, cannot participate. Doxorubicin is a type of chemotherapy, radiotherapy uses radiation to kill cancer cells, and temozolomide is another type of chemotherapy.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other serious health conditions that could interfere with the study treatments cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

  • Doxorubicin

    is a medication used in this trial to help treat glioblastoma, a type of brain cancer. It is being studied to see if it is safe and can be tolerated when given over a longer period, especially after patients have received radiotherapy. Doxorubicin works by interfering with the growth of cancer cells, slowing down or stopping their spread.

  • Temozolomide

    is another medication used in this trial. It is a type of chemotherapy that helps to treat brain tumors by damaging the DNA of cancer cells, which can prevent them from growing and dividing. In this study, it is used in combination with doxorubicin and radiotherapy to see if it improves treatment outcomes for patients with glioblastoma.

What is already known about the treatment

Doxorubicin – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its use in treating glioblastoma, particularly in pediatric and young adult patients. Doxorubicin is primarily used to treat various types of cancer by interfering with the growth of cancer cells. It works by intercalating DNA strands, which disrupts the replication of cancer cells. Doxorubicin is classified as an anthracycline antibiotic, a type of chemotherapy drug.

Investigated diseases

Glioblastoma – Glioblastoma is a type of brain cancer that originates in the glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor's location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, it can lead to increased pressure within the skull, causing further neurological symptoms. Glioblastoma is typically diagnosed through imaging studies and biopsy, revealing its characteristic appearance. The disease is challenging to manage due to its tendency to recur after initial treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519135-41-00Protocol codepGBM-WBRT/DOX2020Estimated enrolment20 patientsSponsorAzienda Ospedaliera Universitaria Meyer IRCCS

sourced from the EU Clinical Trials Register and site verification

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