Not recruitingRare disease

Study on the Safety and Effectiveness of 2-Hydroxyoleic Acid and Temozolomide with Radiotherapy 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, specifically in patients who have been newly diagnosed. The study is testing a new treatment approach that combines a substance called 2-hydroxyoleic acid (2-OHOA) with the standard treatment for glioblastoma, which includes radiotherapy and a medication known as temozolomide. Temozolomide is available in different strengths, such as 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg hard capsules. The trial also involves a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how effective and safe the combination of 2-OHOA with the standard treatment is for patients with glioblastoma. Participants in the study will be randomly assigned to receive either the new treatment combination or the standard treatment with a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will receive their assigned treatment and will be monitored for changes in their condition. The study will look at how long patients live without the cancer getting worse, known as progression-free survival, and overall survival, which is the length of time patients live after starting the treatment. The study will also assess changes in neurological function and quality of life. The trial is expected to continue until enough data is collected to determine the effectiveness and safety of the new treatment approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. Consent is required to participate.
The patient must meet specific criteria, such as being between 18 and 75 years old and having a confirmed diagnosis of glioblastoma.
Step 2
Initial treatment phase
The patient will begin treatment with temozolomide, a medication taken orally in capsule form. The dosage will vary based on the specific needs and condition of the patient.
This phase includes the administration of radiotherapy alongside temozolomide as part of the standard care.
Step 3
Introduction of 2-OHOA
The patient will receive 2-hydroxyoleic acid (2-OHOA), which is provided as a powder for oral suspension. This is an additional treatment to assess its efficacy and safety in combination with the standard care.
The administration of 2-OHOA will be monitored closely to evaluate its effects.
Step 4
Monitoring and assessment
Throughout the trial, the patient's health and response to treatment will be regularly monitored. This includes assessments of neurological function and overall health.
Progression-free survival and overall survival will be evaluated using specific criteria to determine the effectiveness of the treatment.
Step 5
Completion of the trial
The trial is expected to conclude by April 2026. At the end of the trial, the patient's overall health and treatment outcomes will be reviewed.
The results will contribute to understanding the efficacy and safety of 2-OHOA in combination with standard glioblastoma treatments.

Who can join the trial?

13 criteria

You must provide a signed and dated written consent to participate.
You should be able to understand and follow instructions during the trial.
Your age must be between 18 and 75 years old.
You must have a newly confirmed type of brain tumor called **glioblastoma** that is **IDH1 wildtype**. This means a specific genetic test shows a certain result.
You need to be able to swallow and keep down oral medication.
Your **MGMT promoter methylation status** must be checked. This is a specific test related to your tumor.
You should have had surgery to remove part or all of the tumor, and there must be enough tumor tissue available for testing.
Your **Karnofsky Performance Score (KPS)** must be more than 50%. This score measures your ability to perform daily activities.
If you are a woman who can have children, you must have a negative pregnancy test within one week before joining the trial. You and your partner must use reliable birth control during the study and for a certain period after the study ends.
If you are a man who is sexually active and has not had a vasectomy, you must agree to use a barrier method of birth control, like a condom.
Your **bone marrow function** must be adequate, which means having enough healthy blood cells. This includes having a certain level of **neutrophils** (a type of white blood cell), **platelets** (cells that help with blood clotting), and **hemoglobin** (a protein in red blood cells).
Your **liver function** must be adequate, which means having certain levels of **bilirubin** (a substance made by the liver), **AST**, and **ALT** (enzymes that show how well your liver is working).
Your **kidney function** must be adequate, which means having a certain level of **creatinine clearance**. This is a measure of how well your kidneys are working.

Who cannot join the trial?

5 criteria

Patients who have not been newly diagnosed with primary glioblastoma multiforme (a type of brain cancer) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not able to receive the standard treatment of radiotherapy (a treatment using radiation) and TMZ (a type of chemotherapy) cannot participate.
Patients who are part of a vulnerable population, which may include those who cannot give informed consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

2-Hydroxyoleic Acid (2-OHOA)
is an experimental medication being tested for its potential to improve outcomes in patients with newly diagnosed primary glioblastoma. It is being studied to see if it can enhance the effects of standard treatments and help control the progression of the disease.
Radiotherapy
is a standard treatment for glioblastoma that uses high-energy rays to target and kill cancer cells. It is part of the standard care provided to patients in this trial, aiming to reduce the size of the tumor and prevent it from growing.
Temozolomide
is a chemotherapy drug commonly used in the treatment of glioblastoma. It works by damaging the DNA of cancer cells, which can help to stop their growth and spread. In this trial, it is used alongside radiotherapy as part of the standard care treatment.

What is already known about the treatment

2-Hydroxyoleic Acid (2-OHOA) – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating newly diagnosed primary glioblastoma multiforme, a type of brain cancer. It is being evaluated in combination with standard treatments like radiotherapy and temozolomide. The main therapeutic indication is to improve progression-free survival and overall survival in patients. At the molecular level, 2-OHOA is believed to modify the lipid composition of cell membranes, which may affect signaling pathways involved in cancer cell growth. It is classified as a lipid-modifying agent.

Investigated diseases

Newly Diagnosed Primary Glioblastoma Multiforme – Glioblastoma multiforme is an aggressive type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and a tendency to invade surrounding brain tissue, making it difficult to treat. Symptoms often include headaches, seizures, and neurological deficits such as weakness or speech difficulties, depending on the tumor's location. The disease progresses quickly, with tumor cells spreading into nearby brain areas, leading to worsening symptoms. As the tumor grows, it can cause increased pressure within the skull, further affecting brain function. This condition is considered rare and is typically diagnosed through imaging studies and biopsy.