RecruitingPhase 2NCT05023018

NEO100 and High-Grade Meningioma

An Open-Label, Phase 2 Study of NEO100 in Participants With Residual, Progressive or Recurrent High-Grade Meningioma


Sponsor

Neonc Technologies, Inc.

Enrollment

30 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This multi-site, Phase 2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle until disease progression, death or patient withdraw from study for any reason, whichever occurs first.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests NEO100 — a highly purified form of perillyl alcohol, a natural plant compound — as a treatment for high-grade meningioma (a type of brain tumor, WHO Grade II or III) that has come back or kept growing despite prior surgery and radiation. **You may be eligible if...** - You have been diagnosed with WHO Grade II or III meningioma confirmed by pathology - Your tumor is residual (remaining after surgery), progressive, or has recurred - You have already had surgery (at least a minimal safe resection) and radiation therapy - Your tumor is measurable on MRI (at least 10mm in both dimensions) - Your overall health is good enough to participate **You may NOT be eligible if...** - You have a Grade I (benign) meningioma - You have not yet received surgery and radiation - Your tumor is not measurable on imaging - You have significant other medical conditions that could interfere with the study - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNEO100

NEO100 is a purified form of perillyl alcohol.


Locations(3)

University of Southern California

Los Angeles, California, United States

Saint John Cancer Institute

Santa Monica, California, United States

Baylor Scott and White

Dallas, Texas, United States

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NCT05023018