Phase 1 Study of MR-Linac and Temozolomide for High-Grade Glioma
This study is looking at a new way to treat high-grade glioma (a type of brain cancer). It combines a special radiation machine called an MR-Linac System (Elekta Unity) with radiation therapy delivered twice a week for three weeks, and a chemotherapy drug called Temozolomide, taken daily during those three weeks. Researchers want to see how safe this treatment is and if patients can tolerate it. You might be able to join if you are 18 or older, have newly diagnosed high-grade glioma (Grade 3 or 4, IDH wild-type), and have completed surgery with FastGlioma. The main goal is to track any serious side effects for up to one year after radiation treatment starts. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is a Phase 1 interventional study, meaning it's an early-stage trial to test safety. It plans to enroll 20 participants.
- What's involved
- You would receive radiation therapy twice a week for three weeks and take Temozolomide daily during that time. You will be monitored for side effects for up to one year after starting radiation.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to one year after radiation treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07457307
Integrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentNYU Langone HealthInvestigator-initiated
~20 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:MR-Linac SystemRadiation TherapyTemozolomide
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Occurrence of Dose-Limiting Toxicities
Measured over Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Jonathan Yang, MD, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants male or female of age 18 or older
Ability to understand and the willingness to sign a written informed consent document
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Have histologically confirmed, newly diagnosed high grade glioma (histologic grade 3 or 4, IDH wildtype)
Must have completed surgery with FastGlioma
Patients can either be consented before or after surgery. Patients can be a maximum of 6 weeks post-surgery period to the start of MRL-RT.
Ability to undergo radiotherapy with an MR-Linac machine including effective immobilization for the duration of treatment and required MR sequences
Subjects must have adequate bone marrow, liver and kidney function defined as:
Hemoglobin \>/= 9.0 g/dL
Absolute neutrophil count \>/= 1.5 x 109/L
Platelet count \>/= 100 x 109/L
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \</= 2.5 x ULN
Creatinine within normal limits OR measured creatinine clearance (CL) \>50 mL/min OR calculated creatinine clearance (CL) \>50 mL/min as determined by Cockcroft-Gault
Men who partner with a woman of childbearing potential must agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable or barrier method) while on study and for 4 months afterward.
For Female participants:
While on study treatment a participant must not breastfeed or be pregnant
Have a negative highly sensitive (eg, beta-human chorionic gonadotropin \[β-hCG\]) pregnancy test at screening and agree to further pregnancy tests per the protocol.
Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used.
Female participants (pre- or perimenopausal) must use the appropriate highly effective, contraception method within 28 days of the first dose of study treatment.
Prior evidence of IDH mutation by IHC or DNA sequencing (i.e., IDH wild type only)
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Subject is pregnant or planning to become pregnant or nursing (lactating).
Subject is enrolled in another investigational trial and/or is taking investigational medication and/or has been treated with an investigational device \</= 30 days prior to planned procedure date.
Contraindications to MRI examination as per standard MRI screening policy
Contraindication to Gadolinium-based contrast media
Inability to lie flat in a supine position for at least 30 minutes
Inability to tolerate immobilization in a head thermoplastic mask
Prior therapeutic cranial irradiation
Leptomeningeal dissemination of disease
Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
Exclusion
Uncontrolled intercurrent illness
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible.
What this trial measures
- Overall Occurrence of Dose-Limiting ToxicitiesUp to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Measure of safety and tolerability.