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Study of Itraconazole with Radiotherapy and Temozolomide for Patients with Newly Diagnosed Glioblastoma

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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 a type of brain cancer called glioblastoma multiforme (GBM). The study is testing a treatment that combines a medication called itraconazole with standard radiotherapy (RT) and a chemotherapy drug known as temozolomide (TMZ). Itraconazole is usually used to treat fungal infections, but researchers are exploring its potential benefits in treating GBM when used alongside other standard treatments.

The purpose of this study is to find out the highest dose of itraconazole that can be safely given to patients with newly diagnosed GBM while they are also receiving RT and TMZ. This is known as determining the maximum tolerated dose. Participants in the study will take itraconazole in the form of hard capsules by mouth. The study will monitor how well patients tolerate the combination of these treatments over a period of time.

Throughout the study, patients will receive regular check-ups and imaging tests like MRI to track the progress of their treatment. The study aims to gather important information that could help improve treatment options for people diagnosed with GBM 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

    Introduction to the trial

    The trial involves the use of itraconazole in combination with standard treatments for glioblastoma multiforme, a type of brain cancer.

    The main goal is to find the highest dose of itraconazole that can be given safely with radiotherapy and temozolomide.

  2. Step 2

    Eligibility confirmation

    Eligibility is confirmed based on specific criteria, including a confirmed diagnosis of glioblastoma, no prior treatments except surgery, and the ability to undergo MRI scans.

    Participants must be at least 18 years old, have adequate organ function, and be able to swallow capsules.

  3. Step 3

    Treatment initiation

    Participants begin treatment with itraconazole capsules, taken orally. The dosage is determined based on the trial's phase I design.

    Standard radiotherapy and temozolomide are administered concurrently with itraconazole.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the body's response to the treatment and to determine the maximum tolerated dose of itraconazole.

    Participants undergo serial MRI scans to evaluate the treatment's effectiveness.

  5. Step 5

    Completion of treatment

    The trial is expected to continue until March 2026, with the recruitment phase starting in February 2025.

    Upon completion, data will be analyzed to determine the safety and efficacy of the treatment combination.

Who can join the trial?

9 criteria

  • You must have a confirmed diagnosis of **glioblastoma**. This means a doctor has checked your brain tissue and confirmed the presence of this type of brain tumor.
  • You should not have had any previous treatments for your condition, except for surgery. This means no previous radiation therapy, local chemotherapy, or treatments that affect the whole body.
  • You must be able to have regular **MRI** scans. MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of your body.
  • If you were not a candidate for surgery and only had a biopsy, you should be able to receive standard radiation therapy and a drug called **TMZ**.
  • You must be at least 18 years old.
  • Your kidneys and liver should be working well, and your body should be able to produce enough blood cells.
  • You should have an **ECOG performance status** of 2 or less. This is a scale that measures how well you can perform daily activities. A score of 2 means you are up and about more than half the day and can take care of yourself but cannot work.
  • You must be able to swallow whole capsules.
  • You should be able to understand and follow the study requirements and must have signed a document agreeing to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with glioblastoma, which is a type of brain cancer, cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, meaning they need special protection, cannot participate.
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Investigated drugs

  • Itraconazole

    is a medication that is being studied for its potential to enhance the effects of standard treatments in patients with a type of brain cancer called glioblastoma multiforme. It is usually used to treat fungal infections, but in this trial, it is being tested to see if it can help improve the outcomes of cancer treatment when used alongside other therapies.

  • Radiotherapy

    is a common treatment for cancer that uses high-energy rays to target and kill cancer cells. In this trial, radiotherapy is used as a standard treatment for glioblastoma multiforme, and researchers are studying how it works in combination with other medications.

  • Temozolomide

    is a chemotherapy drug that is often used to treat brain tumors like glioblastoma multiforme. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this trial, temozolomide is used along with radiotherapy and itraconazole to see if this combination can be more effective in treating the cancer.

What is already known about the treatment

Itraconazole – Itraconazole is administered orally in the form of capsules or liquid. It is currently being studied in clinical trials for its potential use in treating glioblastoma multiforme, a type of brain cancer. The main therapeutic indication in this trial is to assess its effectiveness when combined with standard radiotherapy and temozolomide. At the molecular level, itraconazole works by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes, and it is being explored for its ability to inhibit angiogenesis, which is the formation of new blood vessels that tumors need to grow. It is classified pharmacologically as an antifungal agent, but its potential anti-cancer properties are under investigation.

Investigated diseases

Glioblastoma – Glioblastoma is a type of brain cancer that originates from 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. The disease is challenging to treat due to its tendency to spread quickly and its resistance to conventional therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519239-40-01Protocol codeIIT-2024/01Estimated enrolment15 patientsSponsorOtto Von Guericke Universitaet Magdeburg

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