Study of AGuIX Nanoparticles and Temozolomide with Radiotherapy 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, which is a fast-growing and aggressive form of cancer that occurs in the brain. The study is testing a new treatment that combines a special type of nanoparticles called AGuIX with standard treatments like radiotherapy and a chemotherapy drug called Temozolomide (TMZ). The AGuIX nanoparticles are designed to enhance the effects of radiotherapy, potentially improving treatment outcomes for patients with newly diagnosed glioblastoma.

The purpose of the study is to find the best dose of AGuIX when used with radiotherapy and Temozolomide, and to see how effective this combination is in treating glioblastoma. The study is divided into two phases. In the first phase, researchers will determine the safest and most effective dose of AGuIX. In the second phase, they will evaluate how well the treatment works by looking at how long patients live without the cancer getting worse over a period of six months. Some participants will receive a placebo instead of AGuIX to compare the results.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will also monitor the overall survival of participants, their response to the treatment, and any side effects they may experience. Additionally, the study will assess the distribution of the nanoparticles in the body and their impact on the tumor environment. The trial is expected to continue until 2027, with ongoing assessments to ensure the safety and effectiveness of the treatment.

1 initial treatment phase

The study begins with the administration of AGuIX nanoparticles through an intravenous infusion. This is a solution that is given directly into the bloodstream.

The purpose of this phase is to determine the recommended dose of AGuIX when used with radiotherapy and Temozolomide (TMZ), a medication taken orally to treat brain tumors.

During this phase, the focus is on identifying any side effects and determining the highest dose that can be given safely.

2 concomitant radiochemotherapy period

This phase involves the combination of radiotherapy and Temozolomide with the recommended dose of AGuIX.

The treatment aims to assess the effectiveness of this combination in controlling the tumor.

The primary goal is to measure the progression-free survival rate at six months, which indicates how long the disease does not worsen.

3 monitoring and assessment

Throughout the study, regular assessments are conducted to monitor the safety and effectiveness of the treatment.

These assessments include measuring the distribution of nanoparticles in the body, overall survival rates, and neurological status using clinical evaluations and questionnaires.

The intake of corticosteroids, which are medications used to reduce inflammation, is also evaluated.

4 follow-up period

After completing the treatment phases, there is a follow-up period to continue monitoring the patient’s health and any long-term effects of the treatment.

The study aims to assess the overall survival rate at six and twelve months after the start of treatment.

The safety profile of AGuIX nanoparticles in combination with radiotherapy and TMZ is evaluated throughout the study.

Who Can Join the Study?

Must have a confirmed diagnosis of grade IV glioblastoma, which is a type of brain cancer, through a biopsy or partial surgery.
If taking corticosteroids (a type of medication), the dose must be stable or decreasing for at least 14 days before joining the study.
Must be able to swallow and keep down oral medication.
Women must have a negative pregnancy test within 7 days before starting the treatment.
Women who can have children and men with partners who can have children must agree to use an approved method of contraception during the study and for at least 6 months after the last treatment.
Must provide signed informed consent, which means agreeing to participate after understanding the study details.
Must be part of a social security system.
Must not have had surgery or only had partial removal of the tumor.
Must have a Karnofsky Performance Status (KPS) of 70% or higher, which measures the ability to perform daily activities.
Must be between 18 and 74 years old.
Must have a life expectancy of at least 6 months.
Must have a platelet count of at least 100,000 per cubic millimeter, which is important for blood clotting.
Must have hemoglobin (Hb) levels of at least 10 grams per liter, which is important for carrying oxygen in the blood.
Must have creatinine levels less than 1.5 times the upper normal limit or a creatinine clearance of at least 50 milliliters per minute, which indicates kidney function.
Must have liver function tests within certain limits: GGT, PAL, ASAT, ALAT less than 3 times the upper normal limit, and bilirubin less than 1.5 times the upper normal limit.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with glioblastoma. Glioblastoma is a type of brain cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Cpxeqk Lsbo Bqrtyj	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	07.03.2022

Trial locations

AGuIX is a type of nanoparticle being studied for its potential to enhance the effects of radiotherapy. In this trial, it is used in combination with radiotherapy to treat newly diagnosed glioblastoma, a type of brain cancer. The goal is to determine the best dose of AGuIX to use with radiotherapy and to see how effective this combination is in stopping the cancer from progressing.

Temozolomide is a chemotherapy drug that is often used to treat brain tumors like glioblastoma. In this trial, it is given alongside radiotherapy and AGuIX to see if the combination can improve treatment outcomes. Temozolomide works by damaging the DNA of cancer cells, which can help to stop their growth and spread.

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 include headaches, seizures, and neurological deficits such as weakness or speech difficulties, depending on the tumor’s location. As the disease progresses, these symptoms may worsen, and new symptoms can develop. Glioblastoma is typically diagnosed through imaging studies and biopsy. It is considered one of the most challenging brain tumors to treat due to its complex and invasive growth patterns.

Trial ID:

2024-517114-15-00

Protocol code:

NANO-GBM

NCT ID:

NCT04881032

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of AGuIX Nanoparticles and Temozolomide with Radiotherapy for Patients with Newly Diagnosed Glioblastoma

What is this study about?

Who Can Join the Study?

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