Mirdametinib + Vinblastine for Pediatric Low-Grade Glioma

Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK

Recruiting Phase 1 Phase 2 Interventional Study
Pediatric Low-grade Glioma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 25
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
St. Justine's Hospital · Other
Who this trial is looking for

This trial is looking for young patients with specific types of brain tumors called pediatric low-grade gliomas. Participants will take a medication called mirdametinib and receive vinblastine chemotherapy over several months.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 2 and 25 years old.
  • I have been diagnosed with a pediatric low-grade glioma.
  • I can provide a tissue sample of my tumor.
  • I am able to take medicine by mouth.
  • I have a life expectancy of more than 6 months.
  • I agree to use effective birth control if I am of childbearing age.
  • I am willing and able to follow the study schedule and requirements.

You may not be able to join if

  • I am currently taking other investigational treatments.
  • I have a history of serious heart problems.
  • I have another active cancer that needs treatment.
  • My tumor has a BRAF V600E mutation.
  • I have had previous cancer treatment like chemotherapy or radiation.
  • I have severe medical conditions that cannot be controlled.
  • I have very high blood pressure.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a 3-part open-label study (feasibility phase, treatment phase and follow-up phase) of orally administered mirdametinib in combination with intravenous vinblastine chemotherapy in patients with PLGG with activation of MAPK pathway. Feasibility Phase: The maximum tolerated/recommended phase 2 dose (MTD/RP2D) of the mirdametinib plus vinblastine combination will be assessed using a modified…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Signed written informed consent prior to study participation. * Study activities compliance: must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by contrast enhanced…
Contacts

Sébastien Perreault, M.D, FRCPC

514-345-4931

s.perreault@umontreal.ca

CONTACT

MIRV Study Team

mirv.study.hsj@ssss.gouv.qc.ca

CONTACT