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A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]

RecruitingEARLY Phase 1Ages 12 Years - anyAllUniversity of Minnesota
NCT06693284 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a single center Phase 0 "window of opportunity" trial for the treatment of newly diagnosed, PRC2 deficient, primary malignant peripheral nerve sheath tumors (MPNSTs) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment for their specific tumor (typically localized radiation followed by surgical resection). Four to eight patients, 12 years of age or older and meeting the study's biomarker inclusion criteria, would be enrolled onto this trial. After voluntary written consent (assent with parent consent for minors) the patient undergoes MRI and PET imaging of the tumor and a needle biopsy to collect tumor is performed. Patients with histone H3K27 trimethylation deficient MPNST, as confirmed by immunohistochemistry, receive a single 28-day course of mirdametinib and vorinostat at standard oral dosing for each.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria. * Diagnosis of suspected MPNST by PET or MRI imaging * Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry * Twelve years of age or older * Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1 st dose of study drug. * Must be able to swallow capsules. * Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib. Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat. * Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment. Exclusion Criteria: * Pregnant or breastfeeding - females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to the 1 st dose of the study drugs. * Significant cardiac disease * Significant eye disease * Radiation therapy or chemotherapy in the past year.
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What it tests

  • mirdametinib and vorinostat
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Where

1 site
University of Minnesota
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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