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New treatment option for Primary Malignant Peripheral Nerve Sheath Tumors
Official title A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]
ClinicalTrials.gov ID: NCT06693284
What this study is testing
What is mirdametinib and vorinostat?
mirdametinib and vorinostat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary malignant peripheral nerve sheath tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
You likely can't join if
- Pregnant or breastfeeding - females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to the 1 st...
- Significant cardiac disease
- Significant eye disease
- Radiation therapy or chemotherapy in the past year.
See the full eligibility 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 section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib. Males with partners of...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.