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Monoterpene
Perillyl Alcohol for Glioblastoma
Phase 1 & 2
Recruiting
Research Sponsored by Neonc Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma, including infratentorial (brainstem, cerebellar) glioma (confirmed by biopsy) and subcortical glioma; or have radiographically-confirmed progression of, recurrent, primary or secondary Grade III astrocytoma.
All patients must be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new way to administer a drug, perillyl alcohol, to patients with brain tumors. The goal is to see if it is safe and effective. Up to 24 patients will be enrolled in the first phase of the trial, and 25 in the second phase. The drug will be administered four times a day for 28 days, and patients will be monitored for side effects and effectiveness.
Who is the study for?
This trial is for patients with Grade IV glioma that has progressed after radiation or temozolomide treatment. They must have a life expectancy of at least three months, be in fair to good physical condition (ECOG 0-2 or KPS ≥60), and not have had recent surgery or chemotherapy. Participants need stable steroid use before consent, adequate organ function, and agree to contraception.Check my eligibility
What is being tested?
NEO100 (perillyl alcohol) is being tested through nasal administration for its safety and effectiveness against recurrent Grade IV glioma. The study includes two phases: Phase 1 determines the maximum tolerated dose via a '3+3' design; Phase 2a treats patients with this dose. Up to six cycles of NEO100 are given daily over a period of four weeks each.See study design
What are the potential side effects?
Specific side effects aren't listed but may include typical reactions related to cancer treatments such as irritation at the administration site, systemic reactions due to absorption of the drug, fatigue, nausea, headaches, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor has worsened or returned after treatment.
Select...
I have been on a stable or decreasing dose of steroids for at least five days.
Select...
My previous treatments with radiation or radiation combined with temozolomide did not work.
Select...
I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 : Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Phase 2 : Number of Participants Who Are Alive Each Month For 6 Months
Phase 2 : Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related To Treatment
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
2Treatment groups
Experimental Treatment
Group I: NEO100 Phase 2AExperimental Treatment1 Intervention
Intranasal delivery of NEO100 (perillyl alcohol) four times a day. Treatment of total of 25 patients at maximum tolerated dose.
Group II: NEO100 Phase 1Experimental Treatment1 Intervention
Intranasal delivery of NEO100 (perillyl alcohol) four times a day, escalation up to four different doses to determine maximum tolerated dose.
Find a Location
Who is running the clinical trial?
Neonc Technologies, Inc.Lead Sponsor
3 Previous Clinical Trials
179 Total Patients Enrolled
1 Trials studying Glioblastoma
134 Patients Enrolled for Glioblastoma
Tom Chen, MD, PhDStudy ChairNeOnc Technologies
2 Previous Clinical Trials
164 Total Patients Enrolled
1 Trials studying Glioblastoma
134 Patients Enrolled for Glioblastoma
Vincent F Simmon, PhDStudy DirectorNeOnc Technologies
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Grade IV glioma has worsened or returned, and I've been on a stable or decreasing steroid dose for 5+ days.I am willing to give blood samples for the study.I finished chemo-radiation within the last 3 months, unless my cancer has grown or spread.I had surgery within the last week.I agree to use birth control during the study.My brain tumor has worsened or returned after treatment.I have received chemotherapy in the last 28 days.I still have side effects from cancer treatment given more than 4 weeks ago.I have been treated with specific cancer drugs before, but not temozolomide.I have a serious illness that is not under control.I have been on a stable or decreasing dose of steroids for at least five days.My previous treatments with radiation or radiation combined with temozolomide did not work.My cancer spread outside the treated area or was confirmed by surgery if within 3 months after radiation.I am willing to give blood samples for the study.My organs and bone marrow are working well.I can take care of myself and perform daily activities.My tumor is larger than 30mm and has multiple focal points.My cancer has a confirmed IDH1 mutation.My cancer has come back or gotten worse more than once.I haven't had cancer, except for skin cancer, in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: NEO100 Phase 1
- Group 2: NEO100 Phase 2A
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.
What additional research has been conducted utilizing Perillyl alcohol?
"Presently, two ongoing trials are studying the efficacy of Perillyl alcohol with none having reached Phase 3. The preponderance of these experiments take place in Seattle, Washington however there exist 5 sites hosting this investigation."
Answered by AI
Are there any openings remaining on this research initiative?
"According to clinicaltrials.gov, this trial is actively searching for enrollees; the initial posting date was April 8th 2016 and it has been updated most recently on September 23rd 2022."
Answered by AI
How many locations are currently facilitating this clinical trial?
"Patients can get access to this clinical trial through Cleveland Clinic in Ohio, the Florida branch of Cleveland Clinic, and University of Southern California. Additionally, 4 other locations are also providing participation opportunities."
Answered by AI
How extensive is the participant pool for this experiment?
"The trial, sponsored by Neonc Technologies, Inc., necessitates that 49 eligible patients be enrolled from multiple locations. These include Cleveland Clinic in Cleveland, Ohio and the Cleveland Clinic Florida located in Weston, Florida."
Answered by AI
Is this experiment a pioneering endeavor?
"Research into perillyl alcohol has been conducted since 2016, initiated by Neonc Technologies Inc.. After the initial study involving 49 patients, it obtained Phase 1 & 2 approval. Currently, this medication is being tested in two trials across 4 cities and one nation."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
65+
< 18
What site did they apply to?
University of Southern California
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
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