Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Cooper Health System

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

70 Participants
are divided into 1 treatment group

Locations

This trial has no 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