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Compares treatment options for Grade 1 Glioma
Official title Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemotherapy
ClinicalTrials.gov ID: NCT05180825
What this study is testing
What is Trametinib?
Trametinib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for grade 1 glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pediatric low-grade glioma (PLGG) is a heterogeneous group of WHO grade I and II brain tumors, associated with a 10-year overall survival of 90%. It is the most common form of primary central nervous system (CNS) tumor arising during childhood, adolescence and young adulthood, accounting for over 30% of CNS tumors in this age group.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- 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...
- Patient may be under guardianship or curatorship (for patient under legal guardianship, authorization is given by the legal representative of the...
- Histologically proven grade 1 glioma/mixed glio-neuronal tumors or pleomorphic xanthoastrocytoma (PXA) confirmed by local referee and the centrally...
- Determination of a negative BRAFv600 mutation by immunohistochemistry and/or molecular methods
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Patients must have adequate renal function within 7 days prior to screening: serum creatinine \ 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- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Caen, France
- Dijon, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nice, France
- Paris, France
- Poitiers, France
- Reims, France
- Rennes, France
- Rouen, France
- Saint-Etienne, France
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Bordeaux, France; Brest, France; Caen, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.