Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study Comparing Trametinib and Vinblastine for Children and Young Adults with Newly Diagnosed Low-Grade Glioma with Wild-Type BRAF Gene

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 tumor called low-grade glioma, which is a slow-growing tumor that can occur in children and young adults. The study is specifically looking at patients with a newly diagnosed low-grade glioma that does not have a certain genetic change known as the BRAF mutation. The trial will compare two treatments: a daily oral medication called Trametinib (also known by its code name Mekinist), which is a type of drug called a MEK inhibitor, and a weekly intravenous medication called Vinblastine, which is a type of chemotherapy.

The purpose of the study is to see if the new treatment with Trametinib is better than the standard treatment with Vinblastine in managing the disease over a period of 18 months. Participants in the study will be randomly assigned to receive either the daily oral Trametinib or the weekly intravenous Vinblastine. The study will last for a total of 72 weeks, during which time the participants will be closely monitored by healthcare professionals. The study aims to improve the current treatment options for patients with this type of brain tumor.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of their treatment. The study will also collect information on how well the tumor responds to the treatment and any side effects that may occur. The goal is to determine if the new treatment can provide better outcomes for patients with low-grade glioma, potentially leading to improved survival rates and quality of life. This research is important for advancing the understanding and treatment of low-grade gliomas in children and young adults.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be assigned to one of two treatment groups. The assignment is random and aims to compare the effectiveness of two different treatments for low-grade glioma.

  2. Step 2

    Treatment group assignment

    The patient will be placed in either the **experimental group** or the **standard treatment group**. The experimental group will receive a daily oral medication called **Trametinib (Mekinist)**, while the standard treatment group will receive a weekly intravenous medication called **Vinblastine**.

  3. Step 3

    Experimental group treatment

    If assigned to the experimental group, the patient will take **Trametinib** orally every day. The dosage will be either 2 mg or 0.5 mg, depending on the specific prescription provided by the healthcare provider. This treatment will continue for 18 months, divided into 18 courses of 4 weeks each.

  4. Step 4

    Standard treatment group

    If assigned to the standard treatment group, the patient will receive **Vinblastine** through an intravenous infusion once a week. This treatment will also continue for 18 months, divided into 18 courses of 4 weeks each.

  5. Step 5

    Monitoring and assessments

    Throughout the treatment period, the patient's health and response to the medication will be closely monitored. This includes regular visits to the healthcare provider, laboratory tests, and imaging studies to assess the tumor's response to treatment.

  6. Step 6

    End of treatment

    After completing the 18-month treatment period, the patient will undergo a final assessment to evaluate the overall response to the treatment. This will include a review of any side effects experienced and the effectiveness of the treatment in managing the tumor.

  7. Step 7

    Follow-up

    Following the end of treatment, the patient will continue to be monitored for up to three years to track long-term outcomes and any potential late effects of the treatment. This includes periodic health assessments and imaging studies.

Who can join the trial?

21 criteria

  • Age must be between 1 month and 25 years.
  • Tumors can be located in the brain areas such as the top part, optic pathway, middle line, and spine.
  • Must have a performance status score of at least 50% on the Karnofsky or Lansky scale, which measures the ability to perform daily activities.
  • Post-surgery treatment is needed if there are severe vision or nerve problems at diagnosis, worsening of these symptoms, or tumor growth seen in scans. Tumor growth is defined as an increase of more than 25% in the solid part of the tumor over at least 3 months or new tumor spread.
  • Infants under one year with certain brain tumors will start treatment right after surgery, regardless of symptom changes.
  • Females who can have children must agree to use effective birth control during treatment and for 6 months after. They must also have a negative pregnancy test before starting the study. Males must use condoms and consider birth control for their partners during treatment and for 4 months after.
  • Must have healthy bone marrow, which means having enough white blood cells, platelets, and hemoglobin.
  • Must have healthy liver function, with specific levels of bilirubin, ALT, AST, and alkaline phosphatase within normal limits.
  • Must have healthy kidney function, with creatinine levels within normal limits and a creatinine clearance rate above 60 ml/min.
  • Must have a normal heart function, with a QTcF interval less than 480 milliseconds and a normal left ventricular ejection fraction (LVEF).
  • Blood pressure must be controlled and within normal limits for age, height, and gender.
  • Must provide signed written consent to participate in the study. For those under 18, consent is needed from legal guardians. Those over 18 must provide their own consent.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures.
  • Must have health insurance or be a beneficiary of a health insurance system.
  • If under legal guardianship, consent must be given by the legal representative. If under curatorship, consent is needed from the patient and their legal curator.
  • Must have a confirmed diagnosis of grade 1 glioma, mixed glio-neuronal tumors, or pleomorphic xanthoastrocytoma (PXA) by local and central pathology review.
  • Must not have a BRAFv600 mutation, confirmed by specific tests.
  • Must have a specific genetic status or fusion related to the tumor.
  • Midline tumors must not have certain histone H3 mutations.
  • Diffuse glioma must not have an IDH1 mutation.
  • Must provide tumor samples for further testing.

Who cannot join the trial?

10 criteria

  • Patients with a different type of tumor than the ones being studied cannot participate.
  • Patients who have a genetic condition called NF1 (Neurofibromatosis type 1) are not eligible.
  • Patients with a specific gene change in the BRAF gene cannot join the study.
  • Patients who are not within the age range specified for the study cannot participate.
  • Patients who are unable to follow the study procedures for any reason are not eligible.
  • Patients who have other medical conditions that might interfere with the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to join the study.
  • Patients who are currently participating in another clinical trial cannot join this study.
  • Patients who have had certain treatments recently that might affect the study results are not eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Trametinib

    This is a medication taken by mouth daily. It is a type of drug known as a MEK inhibitor. In this trial, it is being tested to see if it can improve treatment outcomes for patients with a specific type of brain tumor called low-grade glioma, which has a normal BRAF gene. The goal is to see if Trametinib can be more effective than the current standard treatment.

  • Vinblastine

    This is a medication given through an intravenous (IV) injection once a week. It is a type of chemotherapy used as a standard treatment for certain types of cancer, including low-grade glioma. In this trial, Vinblastine is being used as a comparison to see if the new treatment with Trametinib offers better results for patients.

What is already known about the treatment

  • Trametinib

    This medication is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating certain types of brain tumors, specifically low-grade gliomas with a wild-type BRAF gene. Trametinib is a MEK inhibitor, which means it works by blocking the MEK enzymes involved in cell growth and division, potentially slowing down or stopping the growth of cancer cells. It is classified as a targeted cancer therapy.

  • Vinblastine

    This medication is given through an intravenous (IV) injection. It is a well-established chemotherapy drug used in the treatment of various types of cancer, including brain tumors like low-grade gliomas. Vinblastine works by interfering with the formation of microtubules, which are essential for cell division, thereby inhibiting the growth of cancer cells. It is classified as a vinca alkaloid, a type of chemotherapy agent.

Investigated diseases

  • Grade 1 Glioma

    This is a type of brain tumor that originates from glial cells, which are supportive cells in the brain. It is considered a low-grade tumor, meaning it grows slowly and is less aggressive compared to higher-grade gliomas. These tumors can cause symptoms depending on their location in the brain, such as headaches, seizures, or neurological deficits. Over time, they may increase in size, potentially leading to more pronounced symptoms. Despite their slow growth, they can still impact brain function and require monitoring.

  • Mixed Glio-Neuronal Tumors

    These are rare brain tumors that contain both glial and neuronal cell components. They typically occur in children and young adults and are generally considered low-grade, meaning they grow slowly. Symptoms can vary widely depending on the tumor's location but may include seizures, headaches, or other neurological issues. The progression of these tumors is usually slow, but they can still cause significant symptoms over time. Regular monitoring is often necessary to assess any changes in the tumor's behavior.

  • Pleomorphic Xanthoastrocytoma (PXA)

    This is a rare type of brain tumor that usually affects children and young adults. It is typically a low-grade tumor, meaning it grows slowly and is less likely to spread. PXAs often occur in the cerebral hemispheres and can cause symptoms such as seizures or headaches. Despite their generally slow growth, they can sometimes become more aggressive. Monitoring and follow-up are important to manage any changes in the tumor's characteristics.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508531-30-00Protocol code7830Estimated enrolment134 patientsSponsorLes Hopitaux Universitaires De Strasbourg

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.