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Can a targeted pill outperform chemotherapy for childhood brain tumors?

NCT ID NCT05180825

Disease control Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a daily oral drug called trametinib can better control low-grade gliomas in children and young adults compared to standard weekly vinblastine chemotherapy. The study focuses on patients whose tumors do not have certain genetic changes (BRAF V600 mutation) and who are not associated with NF1. Participants receive either trametinib or vinblastine for 18 months, and researchers will compare how long the tumors stay under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trametinib (an oral MEK inhibitor) compared with vinblastine (a chemotherapy drug given intravenously)
What this could lead to
If trametinib works better than standard chemotherapy, it could become a new first-line treatment for pediatric low-grade glioma, improving tumor response and progression-free survival.
What could go wrong
This is a phase II trial, so results are not guaranteed. Trametinib may not outperform vinblastine, and side effects could be significant. The study is also limited to a specific genetic subgroup of tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age: ≥ 1 month to ≤ 25 years * Signed written informed consent prior to study participation of the legal representatives and the patient if the patient can understand the impact of clinical trial and to give consent. For patients above 18 years, their written informed consent will be obtained. * Patient may be under guardianship or curatorship (for patient under legal guardianship, authorization is given by the legal representative of the patient under guardianship. For patient under curatorship, consent will be obtained from the adult assisted by his or her legal curator * Histologically proven grade 1 glioma/mixed glio-neuronal tumors or pleomorphic xanthoastrocytoma (PXA) confirmed by local referee and the centrally pathology reviewing * Determination of a negative BRAFv600 mutation by immunohistochemistry and/or molecular methods * Systematic determination 7q34 duplication status or KIAA1549-BRAF fusion * Midline tumors without proven histone H3 mutations * Diffuse glioma without IDH1 mutation * Collection of fresh frozen tumor tissues and/or paraffin-embedded samples for further molecular biomarker testing * Sus-tentorial, optic pathway, midline and spine locations allowed * Karnofsky or Lansky ≥ 50% * Criteria for post-surgical treatment: severe visual or neurological symptoms at diagnosis, clinical deterioration of visual or neurological symptoms or radiological progression. The radiological progression is defined as an increase of solid part of the tumor of more than 25% compared to the pre-baseline MRI-imaging over a time period of at least 3 months or the occurrence of new metastatic lesions. * Infants below one year of age with chiasmatic and/or hypothalamic tumor will be treated immediately after surgery, independently from neurological and/or visual evolution * Females of child-bearing potential must be willing to practice highly effective contraception during all treatment and until 6 months after the last dose of study drugs' administration. Additionally, females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to start of study drugs. Boys with reproductive potential must be willing to use condom and consider contraception for partner women of childbearing potential during treatment and until 4 months after the last study drugs' administration. * Patients must have adequate bone marrow function defined as: absolute neutrophil count (ANC) ≥ 1500/µL; platelets ≥ 100,000/µL and hemoglobin ≥ 9.0 g/dl * Patients must have adequate liver function within 7 days prior to screening: bilirubin (sum of unconjugated and conjugated) ≤ 1.5 ULN for age, ALT and AST ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 4 x upper limit of normal, INR/PTT \< 1.5 x upper limit of normal, * Patients must have adequate renal function within 7 days prior to screening: serum creatinine \< 1.5 x upper limit of normal for age and a creatinine clearance \> 60 ml/min for 1.73 m2 * Cardiac function defined as a corrected QT (QTcF) interval \< 480 msec, LVEF ≥ lower limit of normal (LLN) by echocardiogram (ECHO) * Adequate blood pressure control (smaller or equal to the 95th percentile for patient's age, height and gender) * Patients are willing and able to comply with scheduled visits, treatment plan, laboratory tests and study procedures * Guardians (in case of patients under 18 years) or patient if above 18 years must be affiliated to or a beneficiary of health insurance system. Non-inclusion criteria * Patients presenting a neurofibromatosis type 1 (NF1) congenital disease * Pure optic nerve glioma, limited to one nerve and without optic chiasma infiltration. * Completely resected tumors * Previous treatment except tumor surgery * Pregnancy and lactation * Participation in other clinical trials * Prior non-surgical therapy for this tumor * Diffuse intrinsic pontine glioma (DIPG), even if histologically diagnosed as WHO grade II * Subependymal giant astrocytoma (SEGA) in patients with TSC * Patient having a known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or C * Known hypersensitivity to drugs or excipients * History of another malignancy * History of current uncontrolled infection

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Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) childhood low-grade glioma low grade glioma mixed neuronal-glial tumor pleomorphic xanthoastrocytoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Grade 1 glioma Mixed glio-neuronal tumors Pleomorphic xanthoastrocytoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM

    RECRUITING

    Marseille, 13385, France

  • CHU CAEN

    NOT_YET_RECRUITING

    Caen, 14 033, France

  • CHU Strasbourg - France

    RECRUITING

    Strasbourg, 67091, France

  • CHU de REIMS

    NOT_YET_RECRUITING

    Reims, 51100, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Chu Amiens Picardie

    NOT_YET_RECRUITING

    Amiens, 80054, France

  • Chu D'Angers

    RECRUITING

    Angers, 49933, France

  • Chu Dijon Bourgogne

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Chu Grenoble Alpes

    RECRUITING

    Grenoble, 38043, France

  • Chu Limoges

    NOT_YET_RECRUITING

    Limoges, 87042, France

  • Chu Montpellier

    RECRUITING

    Montpellier, 34 295, France

  • Chu Poitiers Chu La Miletrie

    NOT_YET_RECRUITING

    Poitiers, 86022, France

  • Chu Rouen

    NOT_YET_RECRUITING

    Rouen, 76031, France

  • Chu Saint Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42100, France

  • Chu Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31 059, France

  • Chu Tours

    RECRUITING

    Tours, 37044, France

  • Chu de Besancon

    RECRUITING

    Besançon, 25030, France

  • Chu de Brest Morvan

    RECRUITING

    Brest, 29609, France

  • Chu de Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Chu de Nice

    NOT_YET_RECRUITING

    Nice, 06202, France

  • Chu de Rennes

    NOT_YET_RECRUITING

    Rennes, 35203, France

  • Clcc Oscar Lambret Lille

    RECRUITING

    Lille, 59020, France

  • Groupe Hospitalier Pellegrin

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

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