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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited protocol activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11570 | Rockville Centre | New York |
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