NEO100 for Meningioma
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take chemotherapy or investigational agents within 14 days of starting the study treatment. For prior systemic agents, you must wait at least 4 weeks (or 5 half-lives, whichever is shorter) before starting the trial. No concurrent investigational agents or meningioma-directed therapy is allowed during the study.
What data supports the idea that NEO100 for Meningioma is an effective treatment?
The available research does not provide direct evidence that NEO100 is effective for treating Meningioma. Most of the studies focus on its use for glioblastoma, a different type of brain tumor. For instance, clinical trials in Brazil suggested that NEO100 might help patients with recurrent glioblastoma when given through the nose. Another study showed that NEO100 could reduce tumor growth and increase survival in animals with gliomas, a type of brain cancer. However, there is no specific data on its effectiveness for Meningioma.12345
What safety data exists for NEO100 treatment?
NEO100, a highly purified version of perillyl alcohol (POH), has been evaluated for safety in several studies. Oral administration of POH was previously abandoned due to intolerable side effects like nausea, fatigue, and vomiting. However, intranasal delivery has shown promise, with clinical trials in Brazil indicating it is well tolerated and effective for treating recurrent malignant gliomas. A Phase I/IIa clinical trial in the United States is also evaluating the safety and efficacy of intranasal NEO100 for glioblastoma. Preclinical studies in rats have demonstrated improved bioavailability and tolerability of POH when delivered intranasally using a nanoemulsion.34678
Is the drug NEO100 a promising treatment for meningioma?
NEO100, a purified form of perillyl alcohol, shows promise as a treatment because it can cross the blood-brain barrier, which is a major challenge in treating brain-related conditions. It has been tested in clinical trials for brain cancers like glioblastoma, with encouraging results, especially when delivered intranasally. This suggests it could be effective for other brain tumors, such as meningioma.346910
What is the purpose of this trial?
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.
Research Team
Vincent F Simmon, PhD
Principal Investigator
NeOnc Technologies
Patrick Walters
Principal Investigator
NeOnc Technologies
Tom Chen, MD, PhD
Principal Investigator
NeOnc Technologies
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer NEO100 intranasally four times daily on a 28-day treatment cycle until disease progression, death, or withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- NEO100
NEO100 is already approved in United States for the following indications:
- High-grade meningioma
- Recurrent glioblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neonc Technologies, Inc.
Lead Sponsor