NCT07439172RecruitingPhase 2
Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.
A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- 13 Jul 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- The Cooper Health System
- Diseases
- Glioblastoma
- NCT number
- NCT07439172
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 13 Jul 2026 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cooper University HealthCare Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.