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

NCT07439172 Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	The Cooper Health System
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	70
Start date	2026-03
Completion	2029-09

Conditions

• High Grade Gliomas
• Glioblastoma
• Astrocytoma
• Oligodendroglioma

Interventions

• Pre-radiation temozolomide.

Primary outcomes

• Response Rate — Post-operative MRI (day 0) until radiation simulation MRI (day 70).
  Response rate using RANO criteria.