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

NCT07439172 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-242
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Glioma; Glioblastoma; High Grade Glioma; Brain Tumor; Astrocytoma; Oligodendroglioma; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Response rate using RANO criteria.

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

Secondary Outcomes (1)

• Secondary Outcome

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

Study Arms (1)

All Patients

EXPERIMENTAL

Drug: Pre-radiation temozolomide.

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.

All Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cooper Health System: lead
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: collaborator
• University of Virginia: collaborator
• Virginia Commonwealth University: collaborator
• Wake Forest University: collaborator
• Georgetown University: collaborator
• Musella Foundation: collaborator
• Imaging Biometrics, LLC: collaborator
• West Virginia University: collaborator

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuro-Oncologist

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02