High Grade GliomasPhase 2PRCNCT07439172
Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma.
A Phase 2 study testing Pre-radiation temozolomide. in people with High Grade Gliomas and Glioblastoma, run by Cooper Norcross Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High Grade Gliomas, Glioblastoma, Astrocytoma
- What is being tested?
- Pre-radiation temozolomide.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cooper University HealthCare
Camden, New Jersey, 08103
Cooper Research Team, 855-632-2667, ResearchCancer@cooperhealth.edu
Danielle Bazer
About this study
Official title: 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.
- Conditions
- High Grade Gliomas, Glioblastoma, Astrocytoma, Oligodendroglioma
- Being tested
- Pre-radiation temozolomide.
- Keywords
- Glioma, Glioblastoma, High Grade Glioma, Brain Tumor, Astrocytoma, Oligodendroglioma, Temozolomide
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | Not described Receives: Drug: Pre-radiation temozolomide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response rate using RANO criteria.
Measured: Post-operative MRI (day 0) until radiation simulation MRI (day 70).
Secondary outcomes (1)
Secondary Outcome
To assess the safety and tolerability of pre-radiation temozolomide utilizing CTCAE version 5.
Measured: From start of pre-radiation chemotherapy (day 10) until 2 cycles of pre-radiation temozolomide are complete (day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start13 Jul 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Danielle Bazer, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439172
- Sponsor's protocol ID
- 25-242
- Acronym
- PRC
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centered Evaluation of Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma (HGG): An Approach to Drug Screening That Requires Confirmation
- ClinicalTrials.gov ID
- NCT07439172
- Acronym / sponsor ID
- PRC / 25-242
- Conditions
- High Grade Gliomas, Glioblastoma, Astrocytoma, Oligodendroglioma
- Keywords
- Glioma, Glioblastoma, High Grade Glioma, Brain Tumor, Astrocytoma, Oligodendroglioma, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- 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
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: Pre-radiation temozolomide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | All Patients |
Primary outcome
Response Rate
Time frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70).
Response rate using RANO criteria.
1 secondary outcome
Secondary Outcome
Time frame: From start of pre-radiation chemotherapy (day 10) until 2 cycles of pre-radiation temozolomide are complete (day 70)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pre-radiation temozolomide. in people with High Grade Gliomas and Glioblastoma, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Post-operative MRI (day 0) until radiation simulation MRI (day 70).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.