RECRUITING

NEO100 and High-Grade Meningioma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Phase 2 Study of NEO100 in Participants with Residual, Progressive or Recurrent High-Grade Meningioma

Quick Facts

Study Start:2022-07-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05023018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Chris Beardmore
CONTACT
224 218 2408
chris@anovaevidence.com
Chloe Richmond
CONTACT
224 218 2408
chloe@anovaevidence.com

Principal Investigator

Tom Chen, MD, PhD
STUDY_CHAIR
NeOnc Technologies
Vincent F Simmon, PhD
STUDY_DIRECTOR
NeOnc Technologies
Patrick Walters
STUDY_DIRECTOR
NeOnc Technologies

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: Neonc Technologies, Inc.

  • Tom Chen, MD, PhD, STUDY_CHAIR, NeOnc Technologies
  • Vincent F Simmon, PhD, STUDY_DIRECTOR, NeOnc Technologies
  • Patrick Walters, STUDY_DIRECTOR, NeOnc Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-07-01
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Residual, Progressive or Recurrent Grade II or III Meningioma

Additional Relevant MeSH Terms

  • Residual, Progressive or Recurrent Grade II or III Meningioma