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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	03.02.2025

Trial locations

Investigated drugs:

Itraconazole

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.

Investigated diseases:

Glioblastoma

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 ID:

2024-519239-40-01

Protocol code:

IIT-2024/01

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?