OncoMatch/Clinical Trials/NCT05023018
NEO100 and High-Grade Meningioma
Is NCT05023018 recruiting? Yes, currently enrolling (May 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
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)
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 →
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