NCT07439172

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

A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Regulatory

• FDA-regulated drug study