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Radiation Therapy for Recurrent Glioblastoma

This study is testing a type of radiation therapy called "hypofractionation" for people whose glioblastoma (a type of brain cancer) has returned after previous radiation treatment. Glioblastoma often comes back, and there isn't a standard treatment when it does. This trial aims to find the safest and most effective dose of re-irradiation (radiation given again) to treat these recurrent tumors. You may be able to join if you are 18 or older, have grade 4 glioblastoma that has returned, and meet other health criteria. The main goal is to find the maximum tolerated dose (MTD) of this daily re-irradiation.

Study design
This is an interventional study with a planned enrollment of 28 participants. It is a single-arm study, meaning all participants receive the same intervention.
What's involved
You will undergo screening, including a physical exam and blood tests. A tumor tissue sample may also be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, measuring the maximum tolerated dose, is assessed during the DLT period (28 days).

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NCT06344130

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~28 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD of daily re-irradiation in participants with recurrent grade 4 gliomas
Measured over DLT period (28 days)

Conditions

Astrocytoma
Glioma
Recurrent Glioblastoma

Explore related trials

GlioblastomaGliosarcoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Peter GK Mathen, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Rukayat O Salau
[email protected]
(240) 858-3712
Email the study team

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Eligibility criteria

Inclusion

Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.
Age \>= 18.
KPS \>= 70%.
Previous tumor irradiation to curative-intent doses.
Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.
Participants must have adequate organ and marrow function as defined below:
Absolute neutrophil count (ANC) \>= 1,000/microL
Platelets \>= 100,000/microL
Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.
Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.
The ability of a participant to understand and the willingness to sign a written informed consent document.

Exclusion

Recent systemic therapy prior to the initiation of the study therapy as follows:
Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
Temozolomide within 2 weeks.
Cytotoxic chemotherapy within 3 weeks.
Any investigational agents within 2 weeks.
Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.
Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.
Requiring radiation therapy within 12 months prior to the initiation of study therapy.
History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.
Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.
Participants with known or suspected radiation sensitivity syndromes.
Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.

What this trial measures

  • MTD of daily re-irradiation in participants with recurrent grade 4 gliomasDLT period (28 days)

    The number of participants experiencing DLTs within the DLT period will be reported for each hypofractionation schema. The MTD will be identified, and the proportion of participants treated with the MTD experiencing DLT will be reported.