An Open-Label, Phase 2 Study of NEO100 in Participants with Residual, Progressive or Recurrent High-Grade Meningioma
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.
• Patient must be ≥ 12 years of age.
• Patient must have an ECOG performance status of 0-2 or KPS ≥ 60.
• Patient must have an expected survival of at least three months.
• Patient must be willing to provide blood sample for pharmacokinetic study (to assess proper administration of NEO100).
⁃ Patient must have adequate organ and marrow function as defined below:
⁃ White blood cell (WBC) ≥2000/microliter
⁃ Absolute neutrophil count (ANC) ≥ 1,500/microliter
⁃ Platelets ≥ 100,000/microliter
⁃ Hemoglobin ≥9 gm/dl
⁃ AST (SGOT)/ALT (SPGT) ≤ 2.5 × laboratory upper limit of normal (ULN)
⁃ Serum creatinine ≤ 1.5 x laboratory upper limit of normal (ULN) or
⁃ Creatinine clearance (meas or calc) ≥60mL/min for participants with creatinine levels \>1.5x laboratory upper limit of normal (ULN)
⁃ Total serum bilirubin ≤ 1.5 x laboratory upper limit of normal (ULN) except participants with Gilbert's Syndrome who can have a total serum bilirubin of \<5 x laboratory upper limit of normal (ULN)
⁃ 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.
⁃ Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first administration of study drug, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
⁃ A female of child-bearing potential is any woman (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
⁃ i. Has not undergone a hysterectomy or bilateral oophorectomy; or ii. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
⁃ A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to initiating study drug.
⁃ A serum pregnancy test will be repeated immediately if pregnancy is suspected.
⁃ Women must not be breastfeeding.
⁃ Patient must have the ability to understand, and the willingness comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study as confirmed by signing a written informed consent document.