Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma. (PRC)

February 23, 2026 updated by: Danielle Bazer, The Cooper Health System

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologic diagnosis of high-grade glioma
  2. Residual measurable post-operative contrast enhancing tumor
  3. Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.)
  4. Ability to provide informed consent
  5. Willingness to comply with all study procedures and availability for the duration of the study
  6. Male or female, aged 18-80.
  7. Karnofsky Performance Status ³70%.

  8. 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

  9. Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen
  10. 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
  11. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
  12. Patients must have measurable disease as defined by RANO criteria.

Exclusion Criteria:

  1. Patients receiving any other investigational agents are ineligible.
  2. Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection.
  3. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible.
  4. 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.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70).
Response rate using RANO criteria.
Post-operative MRI (day 0) until radiation simulation MRI (day 70).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From start of pre-radiation chemotherapy (day 10) until 2 cycles of pre-radiation temozolomide are complete (day 70)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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