WithdrawnPhase 2

A Study of ONC201 for Refractory Meningioma

Stopped: Protocol not moving forward.

0Started 2026-12

Plain-language summary

The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment. The primary goals of this study are: 1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor 2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Brain imaging demonstrating a meningioma for which resection has been recommended (Arm I) or any subject with pathologically proven meningioma without reasonable surgical options for complete resection, or reasonable radiation therapy options, determined by neurosurgery and radiation oncology opinions (Arm II)
✓. Age \> 18 years old at time of study entry (consent) or adult male or female (For Nebraska, age of consent is ≥19 years old)
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
✓. Adequate organ and marrow function as defined below:
✓. Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, C1D1)
✓. Hemoglobin \>8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to C1D1
✓. Total serum bilirubin \<1.5 X upper limit of normal (ULN), except in cases of Gilbert's disease
✓. Aspartate aminotransferase (AST) (SGOT)/Alanine transaminase (ALT) (SGPT) ≤2 X ULN secondary to tumor

Exclusion criteria

What they're measuring

Evaluation of ONC201 concentration in resected meningioma tissue

Timeframe: Up to 12 months

Evaluation of progression-free survival (PFS)

Timeframe: Up to 18 months

Trial details

NCT IDNCT06012929

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Meningioma trials