What is NEO100 studying for high-grade meningioma?

NEO100 is being studied to understand its safety and effects in treating high-grade meningioma, a serious brain tumor. Researchers want to see if repeated nasal doses can help control tumor growth after surgery or radiation. This trial is sponsored by Neonc Technologies, Inc., aiming to explore new treatment options for patients with recurrent or progressive tumors.

Who may be eligible for this high-grade meningioma clinical trial?

Patients aged 12 years or older with confirmed Grade II or III meningioma that is residual, progressive, or recurrent after surgery and radiation may be eligible. Both males and females can participate. Important factors include stable steroid use, no recent chemotherapy or investigational treatments, and adequate organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this high-grade meningioma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 12Years +

All Genders

ID05023018

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

Led by Neonc Technologies, Inc. · Updated on 2026-03-02

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating NEO100 perillyl alcohol in patients with high-grade meningioma, a type of brain tumor that can be life-threatening and often recurs after surgery or radiation. This open-label Phase 2 trial aims to study the safety, how the body processes NEO100, and its effects on patients with residual, progressive, or recurrent high-grade meningiomas. The study addresses the need for new treatment options since surgery and radiation are not always sufficient to control these tumors. NEO100 is a purified form of perillyl alcohol administered intranasally by the patients themselves four times daily in 28-day cycles. Treatment continues until the disease progresses, the patient dies, or the patient chooses to stop. The study will enroll up to 30 patients who have had prior surgery and radiation and meet certain health criteria. This method of nasal delivery aims to target tumors directly in the brain while potentially reducing systemic side effects. Participants will undergo regular MRI or CT scans to monitor tumor size and progression, blood tests to measure drug levels, and health assessments during treatment. Researchers will measure progression-free survival at six months as the main outcome, along with tumor response and overall survival. The study includes safety monitoring and requires participants to follow treatment schedules and be available for visits until disease progression or withdrawal. The trial is expected to continue through mid-2027.

CONDITIONS

Brief Title

NEO100 and High-Grade Meningioma

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed WHO Grade II or III meningioma that is residual, progressive, or recurrent after surgery and radiation therapy
Residual measurable disease at least 10mm by MRI or progressive disease with 25% size increase or recurrent disease after complete resection
Stable or decreasing steroid dose for at least five days before consent
Failed maximal safe resection and radiation therapy
No chemotherapy or investigational treatments within 14 days prior to study treatment
At least 12 years of age
ECOG performance status 0-2 or Karnofsky performance status 60 or higher
Expected survival of at least three months
Willing to provide blood samples for pharmacokinetic studies
Adequate organ and marrow function as defined by specific blood counts and liver/kidney laboratory values
MRI or CT scan within 14 days prior to study drug start
Agreement to use adequate contraception for females of child-bearing potential and males
Ability and willingness to comply with study visits and treatment schedule

You will not qualify if you...

Chemotherapy, targeted therapy, or study therapy within 14 days prior to study treatment
Completed chemo-radiation within 84 days unless new tumor evidence outside radiation field
Surgery within seven days before informed consent
Cytotoxic chemotherapy within 4 weeks, nitrosoureas/alkylating agents within 6 weeks, or biologic therapies
Prior interstitial brachytherapy within 6 months
Current or planned participation in another investigational trial
Tumor primarily in brainstem or spinal cord
Unrecovered adverse events from prior therapies
Prior treatment with perillyl alcohol
History of allergy to perillyl alcohol
Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
Pregnancy or nursing
New diagnosis or treatment of other cancer within five years except certain skin cancers
Leptomeningeal tumor involvement

Research Team

Chris Beardmore

Chloe Richmond

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