Combining mirdametinib and vorinostat for treating specific nerve tumors in NF1 patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of a short course of mirdametinib and vorinostat in patients with newly diagnosed malignant peripheral nerve sheath tumors (MPNSTs) associated with Neurofibromatosis type 1 (NF1) and specific histone deficiencies. The study aims to enroll 4 to 8 patients aged 12 years or older who meet the biomarker criteria. Participants will undergo imaging and a biopsy before receiving the treatment, followed by a repeat MRI to assess the tumor's response. This early-phase trial serves as a 'window of opportunity' before standard treatment options are initiated.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Robert Galvin, MD — University of Minnesota
• Study coordinator: Allison Fullenkamp
• Email: fulle631@umn.edu
• Phone: 612-625-6125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.