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Study of Troriluzole and ADI-PEG-20 for Patients with Newly Diagnosed and Recurrent Glioblastoma

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What is this study about?

This clinical trial is focused on studying treatments for glioblastoma, a type of brain cancer. The study will evaluate two treatments: Troriluzole, which is taken as a capsule, and ADI-PEG-20, which is given as an injection into the muscle. The purpose of the study is to find out if these treatments can help improve the survival of patients with newly diagnosed or recurrent glioblastoma.

Participants in the study will receive either one of the experimental treatments or a placebo. The study will be conducted in two stages. In the first stage, the goal is to identify which treatments are most effective for different patient subtypes or based on specific biomarkers, which are unique characteristics found in the body. In the second stage, the study will confirm the effectiveness of these treatments to support the development of new medications.

The study will last for several weeks, with Troriluzole being administered for up to 48 weeks and ADI-PEG-20 for up to 104 weeks. Participants will be monitored regularly to assess their response to the treatment and any side effects. The main focus will be on overall survival, which means the time from starting the treatment until death from any cause. Other aspects, such as how long the disease stays stable or how the tumor responds to the treatment, will also be evaluated.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and recent medical tests.

For newly diagnosed patients, a confirmed diagnosis of Grade IV glioblastoma is required, along with recent MRI scans and tumor tissue availability.

For recurrent cases, evidence of disease progression and recent MRI scans are necessary.

2 randomization

Participants are randomly assigned to different treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being tested.

3 treatment administration

Participants receive one of the experimental therapies being evaluated. This may include troriluzole taken orally in capsule form or ADI-PEG-20 administered through intramuscular injection.

The specific dosage and frequency of administration depend on the treatment group assigned during randomization.

4 monitoring and follow-up

Regular monitoring is conducted to assess the participant’s health and response to the treatment. This includes medical examinations, imaging tests, and laboratory tests.

Participants are observed for any side effects or changes in their condition.

5 evaluation of outcomes

The primary outcome measured is overall survival, which is the time from randomization to death from any cause.

Secondary outcomes include progression-free survival, tumor response, and duration of response.

6 completion of the trial

The trial is expected to conclude by December 2026. Participants will be informed of the results and any potential implications for their treatment.

Who Can Join the Study?

  • All patients must be 18 years or older.
  • For patients with recurrent glioblastoma (GBM):
    • A baseline MRI scan must be done within 14 days before starting the trial.
    • A Karnofsky performance status of 70% or higher is required. This is a scale that measures a patient’s ability to perform everyday activities.
    • There must be tumor tissue available from the initial or recurrent surgery.
    • The GBM must be confirmed through a histological examination, which means looking at the tissue under a microscope.
    • There must be evidence of the disease coming back, shown by disease progression using specific criteria called RANO.
    • Use of no more than 4mg of dexamethasone per day within 5 days before starting the trial. Dexamethasone is a medication used to reduce inflammation.
  • For patients with newly diagnosed GBM:
    • The GBM must be confirmed as Grade IV, which is a classification of the tumor’s severity, and must be IDH wild-type, meaning it lacks a specific genetic mutation.
    • An MRI scan must be done within 21 days before starting the trial.
    • Use of no more than 4mg of dexamethasone per day within 5 days before starting the trial.
    • A Karnofsky performance status of 60% or higher is required.
    • There must be tumor tissue available from surgery or biopsy.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Glioblastoma (GBM) cannot participate. Glioblastoma is a type of brain cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial group cannot participate. This refers to specific groups of patients that the study is focusing on.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospices Civils De Lyon Lyon France
Hopital Beaujon Clichy France
Uonmdjodiu Hlwamgiz Cmmdyvt Cologne Germany
Agkzpwikll Ppdkvrye Hrknebyr Df Mcarmhynf Marseille France
Gycxbr Ujuwfqqtkl Fxoifeybq Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.06.2021
Germany Germany
Not recruiting
01.06.2021

Trial locations

Investigated drugs:

GBM AGILE: This is a global adaptive trial designed to evaluate multiple treatment regimens for patients with newly diagnosed and recurrent glioblastoma (GBM). The trial aims to identify experimental therapies that can improve overall survival for GBM patients. It also seeks to determine if specific patient subtypes or biomarkers benefit uniquely from these treatments. The trial is conducted in two stages: the first stage screens for effective therapies, and the second stage confirms the efficacy of these therapies to support new drug applications.

Investigated diseases:

Glioblastoma – Glioblastoma is a type of aggressive brain tumor that originates from glial cells, which support nerve cells in the brain. It is known for its rapid growth and tendency to invade surrounding brain tissue, making it difficult to treat. Symptoms often include headaches, seizures, and neurological deficits, which can vary depending on the tumor’s location in the brain. As the disease progresses, these symptoms may worsen, and new symptoms can develop due to increased pressure on the brain. Glioblastoma is the most common and malignant form of primary brain tumor in adults. It is characterized by its heterogeneity, meaning the tumor can have different cell types and genetic mutations within the same tumor mass.

Trial ID:
2024-511452-40-00
Protocol code:
GCAR-7213
NCT ID:
NCT03970447
Trial Phase:
Therapeutic use (Phase IV)

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