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.
NEO100 and High-Grade Meningioma
An Open-Label, Phase 2 Study of NEO100 in Participants With Residual, Progressive or Recurrent High-Grade Meningioma
Meningioma
All genders
18+
Recruiting now
Overview
Principal Investigator: Soma Sengupta
Contact Us
Latoya Marshall
Study details
Inclusion Criteria
- 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.
-Residual disease is defined as residual measurable disease (without a requirement for progression). Residual measurable disease is defined by bidimensionally measurable lesions with clearly defined margins by MRI scan(s) with a minimum diameter of 10mm in both dimensions.
-Progressive disease is defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area). The change must occur between scans separated by no more than 24 months.
-Recurrent disease is defined as new evidence of measurable disease following complete resection (10mm in both dimensions).
- Be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.
. - Participants must have failed maximal safe resection and radiation therapy
Exclusion Criteria
- Patients who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days (or 5 half-lives, whichever is shorter) of study treatment.
- Patient has completed chemo-radiation within the last 84 days prior to the first administration of study drug, unless new contrast enhancement is outside of radiation field, or there is tissue proven recurrence or progression.
- Patient has had surgery within seven days prior to the date of informed consent.
Study Requirements
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 radiographically-confirmed residual, progressive or recurrent high-grade meningioma. There will be up to 30 patients enrolled into the study to enroll 28 evaluable patients. NEO100 will be self-administered four times daily for a 28-day treatment cycle until disease progression, death or patient withdraw for any reason, whichever occurs first.