About this trial
Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read.
First, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.
Eligibility criteria
Qualifiers
Pathologic diagnosis of high-grade glioma
Residual measurable post-operative contrast enhancing tumor
Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)
Ability to provide informed consent
Disqualifiers
Patients receiving any other investigational agents are ineligible.
Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
Trial design
Treatments tested in this trial
- Pre-radiation temozolomide.
Treatment groups
Locations
Sponsors and collaborators
The Cooper Health System
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator
University of Virginia
Collaborator
Virginia Commonwealth University
Collaborator
Wake Forest University
Collaborator
Georgetown University
Collaborator
Musella Foundation
Collaborator
Imaging Biometrics, LLC
Collaborator
West Virginia University
Collaborator