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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

High Grade Gliomas Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pathologic diagnosis of high-grade glioma
Residual measurable post-operative contrast enhancing tumor
Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)
Ability to provide informed consent
Willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18-80.
Karnofsky Performance Status ³70%.
Patients must have the following organ and marrow functions:

Absolute neutrophil count ≥1,500/µL Platelets ≥100,000/µL Hemoglobin ≥ 9 g/dL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)/ALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL/min/1.73m2 APTT/PTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal

Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen
For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Patients must have measurable disease as defined by RANO criteria.

Exclusion criteria

Patients receiving any other investigational agents are ineligible.
Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible.
Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.

Treatment and study plan

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.

Primary outcomes

Response Rate

Time frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70).

Response rate using RANO criteria.

Secondary outcomes

Secondary Outcome

Time frame: From start of pre-radiation chemotherapy (day 10) until 2 cycles of pre-radiation temozolomide are complete (day 70)

To assess the safety and tolerability of pre-radiation temozolomide utilizing CTCAE version 5.

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Collaborators

Georgetown University
Imaging Biometrics, LLC
Musella Foundation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
University of Virginia
Virginia Commonwealth University
Wake Forest University
West Virginia University

Registry information

Official study title

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

Acronym: PRC

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Feb 27, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting