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PLGG – MEKTRIC (Pediatric Low Grade Glioma – MEKinhibitor TRIal vs Chemotherapy)
EU CTIS ID: 2023-508531-30-00
What this study is testing
improve the current standard treatment regimen expecting a superiority of the experimental arm (e.g. MEK inhibitor, daily Trametinib (Mekinist©)) vs standard therapy (e.g. weekly IV Vinblastine) during a length of 18 courses (4 weeks each, a total of 72 weeks) in the group of non-NF1 PLGGs, characterized by a wild-type BRAF gene. This expected superiority of the 3-year PFS is estimated to 20%.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age: ≥ 1 month to ≤ 25 years
- • 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.
You likely can't join if
- • Patients presenting a neurofibromatosis type 1 (NF1) congenital disease
- • 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
- Patients receiving government medical aid (Aide Médicale de l'Etat - AME)
See the full eligibility criteria
Who can join
- • Age: ≥ 1 month to ≤ 25 years
- • 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)
- • 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.
- • 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.
- • 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
What rules you out
- • Patients presenting a neurofibromatosis type 1 (NF1) congenital disease
- • 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
- Patients receiving government medical aid (Aide Médicale de l'Etat - AME)
- • 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
- • Pure optic nerve glioma, limited to one nerve and without optic chiasma infiltration.
- • Completely resected tumors
- • Previous treatment except tumor surgery
- • Pregnancy and lactation
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.