Actively Recruiting
NEO100 and High-Grade Meningioma
Led by Neonc Technologies, Inc. · Updated on 2026-03-02
30
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NEO100 and High-Grade Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed WHO Grade II or III meningioma that is residual, progressive, or recurrent after at least safe resection and radiation therapy
- Residual disease defined by measurable lesions at least 10mm in both dimensions on MRI
- Progressive disease defined as at least 25% increase in lesion size within 24 months
- Recurrent disease defined as new measurable disease after complete resection
- Stable or decreasing steroid dose for at least 5 days before consent
- Failed maximal safe resection and radiation therapy
- No limit on number of prior surgeries, radiation or systemic therapies if criteria met
- No chemotherapy or investigational agents within 14 days before study treatment
- At least 4 weeks from prior cytotoxic chemotherapy or biologic therapies (6 weeks for nitrosoureas/alkylating agents)
- No concurrent investigational agents or meningioma-directed chemotherapy or radiation during study
- At least 12 weeks from completion of radiation therapy unless new tumor outside radiation field with progression
- At least 28 days and full recovery from surgical resection
- Meningiomas from prior radiation therapy allowed
- At least 7 days from stereotactic biopsy
- Recovery to grade 1 or baseline from prior therapy adverse events
- Age 12 years or older
- ECOG performance status 0-2 or Karnofsky performance status 60
- Expected survival of at least 3 months
- Willingness to provide blood samples for pharmacokinetics
- Adequate organ and marrow function including specified blood count and chemistry limits
- MRI or CT within 14 days before starting study drug
- Women of childbearing potential and men must use birth control during and after study
- Negative pregnancy test for women of childbearing potential within 7 days before starting drug
- Women must not be breastfeeding
- Ability to understand and comply with study requirements
You will not qualify if you...
- Chemotherapy, targeted therapy, or investigational treatment within 14 days before study treatment
- Completed chemo-radiation within 84 days before study treatment unless new tumor outside radiation field or confirmed recurrence
- Surgery within 7 days before consent
- Cytotoxic chemotherapy within 4 weeks (or 5 half-lives), nitrosoureas/alkylating agents within 6 weeks, or biologics before study
- Interstitial brachytherapy within 6 months before study
- Participation in another clinical trial with investigational agents or devices
- Tumor primarily in brainstem or spinal cord
- Not recovered from adverse events of prior therapies
- Prior treatment with perillyl alcohol
- History of allergic reaction to perillyl alcohol
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, psychiatric or social issues limiting compliance
- Pregnant or nursing women
- New cancer diagnosis or treatment other than high-grade meningioma within 5 years except certain skin cancers
- Leptomeningeal tumor involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Saint John Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
3
Baylor Scott and White
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
C
Chris Beardmore
CONTACT
C
Chloe Richmond
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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