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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07439172 on ClinicalTrials.gov