An Open-Label, Phase 2 Study of NEO100 in Participants With Residual, Progressive or Recurrent High-Grade Meningioma
Neonc Technologies, Inc.
Summary
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.
Description
Meningiomas are the most common primary brain tumor with an incidence rate of 8.33 per 100,000. They originate from the meningeal (dural) coverings of the brain and spinal cord. Although the majority of meningiomas are benign, these tumors can grow slowly until they are very large, if left undiscovered, and, in some locations can be severely disabling and/or life-threatening. There is a relative paucity of prospective clinical trials that provide an evidenced-based agreed upon approach to managing meningioma. Furthermore, uniformly applied guidelines have been difficult to achieve given the t…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Patient must: 1. 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. 1. 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. 2. Progressive disease is defined as an increase in size of the measurab…
Interventions
- DrugNEO100
NEO100 is a purified form of perillyl alcohol.
Locations (3)
- University of Southern CaliforniaLos Angeles, California
- Saint John Cancer InstituteSanta Monica, California
- Baylor Scott and WhiteDallas, Texas