Study on Mirdametinib for Treating Central Nervous System Tumors

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07539441

This clinical trial is testing the safety and effectiveness of a drug called mirdametinib for treating tumors in the central nervous system, specifically glioma and neurohistiocytosis.

Patient Parameters

Program Overview

The aim of this study is to determine if mirdametinib is a safe and effective treatment option for people with tumors in the central nervous system, such as glioma and neurohistiocytosis.

Eligibility Criteria

Exclusion Criteria

  • Pregnant or nursing women cannot participate.
  • Participants cannot be involved in another treatment study at the same time, although joining non-treatment registries is allowed.
  • Cannot have received any tumor-targeting treatments like chemotherapy or experimental drugs within 28 days before starting mirdametinib.
  • Cannot use medications that strongly affect liver enzymes (CYP3A).
  • Cannot have a history of allergic reactions to mirdametinib or similar drugs.
  • Must not have serious active infections; participants must be fever-free for at least 48 hours.
  • Cannot have uncontrolled or severe medical conditions.
  • Cannot have significant heart disease within 6 months before starting treatment, including severe heart failure or recent heart attacks.
  • Cannot have significant eye diseases within 6 months before starting treatment, like central retinal vein occlusion.
  • Cannot have any condition or treatment that might interfere with the study results or participation.
  • For Cohort A: Patients with specific genetic mutations outside the MAPK pathway are not eligible.

On Study Guidelines:

  • Patients with blood, kidney, or liver issues due to their disease may join if the investigator believes mirdametinib could help.
  • For Cohort A: No prior therapy is required due to the limited effectiveness of standard treatments for CNS tumors and neurohistiocytosis.
  • Female participants who can become pregnant must use effective birth control during the study and for 6 weeks after. Male participants with partners who can become pregnant must use birth control during the study and for 3 months after. If a participant becomes pregnant or suspects pregnancy, they should inform their doctor immediately.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited protocol activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11570Rockville CentreNew York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.