NCT07439172 · The Cooper Health System
Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.
(PRC)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Response Rate
Time frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70).
Response rate using RANO criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Camden, New Jersey
Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, University of Virginia, Virginia Commonwealth University, Wake Forest University, Georgetown University, Musella Foundation, Imaging Biometrics, LLC, West Virginia University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations