Study on the Effects of Losartan Potassium on Brain Tumors in Patients with Glioblastoma or Brain Metastases from Non-Small-Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the effects of the medication losartan on certain types of brain tumors. The diseases being studied include glioblastoma, which is a type of brain cancer, and brain metastases from non-small-cell lung cancer (NSCLC). The treatment involves using different doses of Cozaar, which contains the active ingredient losartan potassium, available in 12.5 mg, 50 mg, and 100 mg film-coated tablets. The purpose of the study is to understand how losartan affects blood flow and the pressure caused by solid stress in brain tumors.

Participants in the study will take the medication orally over a period of time, and their progress will be monitored through various medical imaging techniques, such as MRI (Magnetic Resonance Imaging). These imaging techniques help in assessing changes in blood flow and the physical stress within the tumors. The study aims to observe how the tumors respond to the medication over time, with regular check-ups and imaging sessions scheduled throughout the study period.

The study will also track changes in the participants’ neurological performance and quality of life, using established scoring systems like the Karnofsky Performance Score (KPS) and the Eastern Cooperative Oncology Group (ECOG) scores. Additionally, the study will monitor the overall survival rates and any side effects experienced by participants during the treatment. The trial is expected to continue until the end of 2025, providing valuable insights into the potential benefits of losartan for patients with these specific brain tumors.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and ability to undergo MRI exams.

Participants must have a confirmed diagnosis of either glioblastoma or brain metastases from non-small-cell lung cancer.

2 baseline assessment

Initial assessments include MRI scans to measure brain tumor characteristics and blood tests to evaluate organ function.

These assessments establish a baseline for future comparisons.

3 medication administration

Participants receive losartan, an oral medication, in the form of film-coated tablets.

Dosages include 12.5 mg, 50 mg, or 100 mg, depending on individual requirements and study protocol.

4 treatment schedule

The treatment involves taking losartan daily, with dosage adjustments as needed based on response and tolerance.

Regular follow-up visits are scheduled to monitor progress and adjust treatment as necessary.

5 follow-up assessments

Follow-up MRI scans are conducted at specified intervals to assess changes in brain tumor perfusion and solid stress.

These intervals include days 14-16, 28-30, and 42-44 for glioblastoma patients, and days 90-14, 180-14, and 270-14 for patients with brain metastases.

6 evaluation of outcomes

Primary outcomes focus on changes in brain blood flow and solid stress, measured through MRI.

Secondary outcomes include changes in neurological performance, quality of life, and overall survival rates.

7 completion of study

The study is expected to conclude by December 31, 2025, with final assessments and data analysis.

Participants’ overall health and treatment responses are evaluated to determine the effectiveness of losartan in managing brain tumors.

Who Can Join the Study?

Have a confirmed diagnosis of glioblastoma (a type of brain tumor) or at least one confirmed brain metastasis from non-small-cell lung cancer.
Provide documentation on specific genetic markers related to the disease, such as MGMT promoter methylation and IDH gene mutation (for glioblastoma patients only).
Have organ functions that are strong enough to handle the study treatment, as determined by the study doctor.
If a female patient can have children, she must use highly effective birth control methods and avoid pregnancy during the study and for at least 14 days after the last dose.
Be able to understand and willing to sign a consent form agreeing to participate in the study.
Be able to undergo an MRI exam, which is a type of scan that uses a contrast agent to help see the brain more clearly.
Have a measurable brain tumor, meaning it can be accurately measured using an MRI scan.
Be at least 18 years old.
Be eligible to receive the study drug losartan according to the study rules and the doctor’s assessment.
Have an ECOG performance status of 2 or less, which means being able to carry out daily activities with some limitations.
Have a life expectancy of more than 3 months from the start of treatment.
Have a history of brain surgery if participating in the glioblastoma study.
Be scheduled for treatments like chemotherapy, radiotherapy, or surgery, depending on the specific study group.

Who Cannot Join the Study?

Patients with other types of cancer that are not specified in the study.
Patients who have had previous treatment that might interfere with the study results.
Patients with severe medical conditions that could make participation unsafe.
Patients who are unable to follow the study procedures or instructions.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients with allergies to the study medication or its ingredients.
Patients who have had a recent major surgery.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.11.2019

Trial locations

Investigated drugs:

Losartan Potassium

Losartan is a medication used in this study to explore its effects on blood flow and mechanical stress in brain tumors. It works by blocking certain receptors in the body, which can help relax blood vessels and improve circulation. The study aims to understand how different amounts of losartan can influence these factors in patients with brain tumors.

Investigated diseases:

Glioblastoma

Brain metastases from non-small-cell lung cancer (NSCLC) – This condition occurs when cancer cells from a primary lung tumor spread to the brain. The metastases can cause various neurological symptoms depending on their size and location in the brain. As the disease progresses, these symptoms may worsen, potentially affecting cognitive and motor functions. The growth of these metastases can lead to increased pressure within the skull, causing headaches and other related symptoms. The progression of brain metastases can vary, with some growing rapidly while others remain stable for a period.

Glioblastoma – Glioblastoma is an aggressive type of brain tumor that originates from glial cells. It is characterized by rapid growth and a tendency to infiltrate surrounding brain tissue, making it challenging to manage. Newly diagnosed glioblastomas often present with symptoms such as headaches, seizures, and neurological deficits. Recurrent glioblastomas are those that return after initial treatment, often with more aggressive behavior. The tumor’s progression can lead to increased intracranial pressure and worsening neurological symptoms. Glioblastomas are known for their heterogeneity, meaning they can vary significantly in their cellular composition and behavior.

Trial ID:

2023-507575-22-00

NCT ID:

NCT20180032

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Losartan Potassium on Brain Tumors in Patients with Glioblastoma or Brain Metastases from Non-Small-Cell Lung Cancer

What is this study about?

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