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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 belowSelect...
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.
Select...
I can take care of myself and perform daily activities.
Select...
I am 12 years old or older.
Select...
I understand and agree to follow the study's schedule and requirements.
Select...
My tumor is smaller than 30 mm and I only have one tumor.
Select...
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
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 • NCT0060863452%
Mild Rash, Redness, Erythema
7%
SCC in treatment area
4%
Bowel Obstruction
4%
BCC outside of treatment area
4%
SCC outside of treatment area
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Neonc Technologies, Inc.Lead Sponsor
3 Previous Clinical Trials
198 Total Patients Enrolled
Vincent F Simmon, PhDStudy DirectorNeOnc Technologies
1 Previous Clinical Trials
49 Total Patients Enrolled
Patrick WaltersStudy DirectorNeOnc Technologies
2 Previous Clinical Trials
183 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with perillyl alcohol before.My meningioma is Grade II or III and has come back or gotten worse after surgery and radiation.I had a specific radiation treatment called brachytherapy less than 6 months ago.My organs and bone marrow are working well.My cancer has spread to the lining of my brain and spinal cord.I've had a recent MRI or CT scan and my steroid use has been stable or decreasing.I had surgery within the last week.I agree to use effective birth control during and after the study for the specified times.I have had any number of surgeries, radiation, or drug treatments.I haven't had cancer, except for certain skin cancers, in the last 5 years.I can take care of myself and perform daily activities.I have been on a stable or decreasing dose of steroids for at least 5 days.I am 12 years old or older.You have to be okay with giving a blood sample for a study about how the medication NEO100 works in your body.I understand and agree to follow the study's schedule and requirements.You have had allergic reactions to perillyl alcohol in the past.I have recovered from major side effects of my previous treatment, except for hair loss and low lymphocyte count.I finished chemo-radiation within the last 84 days or have proof of cancer growth.My cancer is mainly in my brainstem or spinal cord.I am still experiencing side effects from cancer treatments.I haven't had chemotherapy or targeted therapy in the last 14 days or 5 half-lives, whichever is shorter.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My tumor is smaller than 30 mm and I only have one tumor.I haven't had chemotherapy, nitrosoureas, alkylating agents, or biologic therapies recently.My cancer did not respond to surgery and radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with high-grade meningioma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How much risk is associated with individuals who have been diagnosed with high-grade meningioma?
"The safety of high-grade meningioma is estimated to be a 2 on the 1 to 3 scale. This evaluation was drawn from Phase 2 trial data that supports safety, yet lacks empirical evidence for efficacy."
Answered by AI
Is the research being conducted innovative in nature?
"Presently, 4 cities and 1 nation are hosting trials for Patients with high-grade meningioma. Neonc Technologies, Inc., sponsored the initial clinical trial back in 2016; this study comprised of 49 participants and achieved its Phase 1 & 2 drug approval stage. Since then, a further two investigations have been conducted."
Answered by AI
Does this medical experiment have any unfilled vacancies for participants?
"Affirmative. Clinicaltrials.gov indicates that this medical trial is presently recruiting participants, with the original posting date of July 1st 2022 and most recent edits occurring on September 23rd 2022. A total of 30 individuals must be sourced from a single site for study inclusion to occur."
Answered by AI
Is there any literature that looks into the efficacy of treatments for those with high-grade meningioma?
"Presently, there are 2 ongoing clinical trials for Patients with high-grade meningioma in the pre-Phase 3 stages of testing. These tests are largely administered at five distinct medical sites located around Seattle, Washington."
Answered by AI
How many participants are being maximally enrolled in this experiment?
"Affirmative. Clinicaltrials.gov reveals that recruitment for this trial, which first opened on July 1st 2022, is still ongoing and looking to enroll 30 participants across a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Puerto Rico
What site did they apply to?
University of Southern California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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