Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.
NCT07439172 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-02-27
Summary
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.
Conditions
- High Grade Gliomas
- Glioblastoma
- Astrocytoma
- Oligodendroglioma
Interventions
- DRUG
-
Pre-radiation temozolomide.
Patients will receive 2 cycles of pre-radiation temozolomide (200mg/m\^2). Cycles are 28-days in length. Participants will take temozolomide on days 1-5 of the 28-day cycle.
Sponsors & Collaborators
-
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
collaborator UNKNOWN -
University of Virginia
collaborator OTHER -
Virginia Commonwealth University
collaborator OTHER -
Wake Forest University
collaborator OTHER -
Georgetown University
collaborator OTHER -
Musella Foundation
collaborator UNKNOWN -
Imaging Biometrics, LLC
collaborator INDUSTRY -
West Virginia University
collaborator OTHER -
The Cooper Health System
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2028-09-30
- Completion
- 2029-09-30
- FDA Drug
- Yes
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