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Monoterpene

NEO100 for Meningioma

Phase 2

Recruiting

Research Sponsored by Neonc Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed.

MRI (or CT if MRI contraindicated) within 14 days prior to start of study drug. Corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening scan and the start of treatment, a new baseline scan is required.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a drug called NEO100 for people with a type of brain tumor called meningioma.

Who is the study for?

This trial is for patients with high-grade meningioma that's come back or hasn't fully been removed by surgery. They should have a life expectancy of at least three months, be over 12 years old, and not have tumors larger than 30 mm or in multiple places. Participants need to be stable on steroids for five days before consent and agree to use contraception. Those who've had certain recent treatments or uncontrolled illnesses can't join.Check my eligibility

What is being tested?

The study tests NEO100 (perillyl alcohol) given four times daily over a 28-day cycle, up to twelve cycles unless the disease progresses or the patient passes away. Up to thirty patients will take part, aiming for twenty-nine evaluable participants. The trial checks how safe NEO100 is, how it moves through the body (pharmacokinetics), and its effectiveness against residual or recurring high-grade meningioma.See study design

What are the potential side effects?

While specific side effects of NEO100 are not listed here, common ones may include allergic reactions as noted in exclusion criteria; also potential risks typically associated with clinical trials such as fatigue, nausea, headaches could occur based on similar compounds' profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My meningioma is Grade II or III and has come back or gotten worse after surgery and radiation.

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I've had a recent MRI or CT scan and my steroid use has been stable or decreasing.

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I can take care of myself and perform daily activities.

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I am 12 years old or older.

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I understand and agree to follow the study's schedule and requirements.

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My tumor is smaller than 30 mm and I only have one tumor.

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My cancer did not respond to surgery and radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival as six months (PFS6).

Secondary outcome measures

Objective Tumor response to NEO100 as determined by RANO criteria

Overall survival

Perillic acid measurement

Side effects data

From 2009 Phase 2 trial • 89 Patients • NCT00608634

52%

Mild Rash, Redness, Erythema

SCC in treatment area

Bowel Obstruction

BCC outside of treatment area

SCC outside of treatment area

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Low Dose POH 0.3%

High Dose POH 0.76%

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with high-grade meningiomaExperimental Treatment1 Intervention

30 patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma

0 / 7Eligibility criteria met