OncoMatch/Clinical Trials/NCT05023018
NEO100 and High-Grade Meningioma
Is NCT05023018 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies NEO100 for residual, progressive or recurrent grade ii or iii meningioma.
Treatment: NEO100 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Disease stage
Required: Stage II, III (WHO)
Grade: IIIII (WHO)
WHO Grade II or III meningioma that is residual, progressive or recurrent
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: surgical resection
following at least minimally safe resection and radiation therapy
Must have received: radiation therapy
following at least minimally safe resection and radiation therapy
Cannot have received: chemotherapy
Exception: no chemotherapy within 14 days (or 5 half-lives, whichever is shorter) of study treatment
No chemotherapy, other investigational agents within 14 days of study treatment
Cannot have received: cytotoxic chemotherapy
Exception: must be at least 4 weeks (or 5 half-lives, whichever is shorter) from prior cytotoxic chemotherapy (6 weeks from nitrosoureas/alkylating agents) or biologic therapies
must be at least 4 weeks (or 5 half-lives, whichever is shorter) from other prior cytotoxic chemotherapy (6 weeks from nitrosoureas/alkylating agents) or biologic therapies
Cannot have received: interstitial brachytherapy
Exception: no interstitial brachytherapy within 6 months of start of study therapy
Prior treatment with interstitial brachytherapy within 6 months of start of study therapy
Cannot have received: perillyl alcohol
Patient has had prior treatment with perillyl alcohol
Lab requirements
Blood counts
WBC ≥2000/microliter; ANC ≥ 1,500/microliter; Platelets ≥ 100,000/microliter; Hemoglobin ≥9 gm/dl
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured or calculated) ≥60mL/min for participants with creatinine levels >1.5x ULN
Liver function
AST (SGOT)/ALT (SPGT) ≤ 2.5 × ULN; total serum bilirubin ≤ 1.5 x ULN except participants with Gilbert's Syndrome who can have a total serum bilirubin of <5 x ULN
Patient must have adequate organ and marrow function as defined below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Southern California · Los Angeles, California
- Saint John Cancer Institute · Santa Monica, California
- Baylor Scott and White · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05023018 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, cytotoxic chemotherapy, interstitial brachytherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify