A Study of ONC201 for Refractory Meningioma

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

Patients will be enrolled in one of two arms, either the presurgical arm or the treatment arm. Patients who will be undergoing surgery to remove their meningioma will be enrolled to Arm I. Patients who have previously received treatment for their meningioma but have exhausted all reasonable treatment options will be enrolled to Arm II. All patients will take the study medication, ONC201, by mouth once per week at a dose of 625 mg. - Arm I patients will receive two doses of ONC201 prior to surgery, with the second dose occurring approximately 24 hours before surgery. - Arm II patients will receive one 625 mg dose of ONC201 per week until disease progression or intolerable toxicity. Primary Objectives 1. To evaluate the concentration of ONC201 in resected meningioma tissue (Arm I) 2. To measure progression-free survival in patients receiving ONC201 who have exhausted all other reasonable treatment options (Arm II) Secondary Objectives 1. To evaluate tumor response via radiographic imaging following treatment with ONC201 2. To correlate dopamine receptor D2 (DRD2) expression with tumor response to treatment via molecular studies performed on archival and fresh tissue 3. To determine overall survival 4. To determine the efficacy of adding bevacizumab to ONC201 in patients who have progressed on ONC201 alone ;

Study Design

Related Conditions & MeSH terms

Meningioma

Clinical Trial Details

NCT number	NCT06012929
Study type	Interventional
Source	University of Nebraska
Contact	Erin Rogers, MS
Phone	402-559-0963
Email	erogers@unmc.edu
Status	Not yet recruiting
Phase	Phase 1
Start date	April 2024
Completion date	April 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.