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

Sponsor
The Cooper Health System
Study ID
NCT07439172
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Pre-radiation temozolomide. — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Patients

Primary Outcome Measure

Response Rate [ Time Frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70). ]

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