Recruiting
Phase 1

Re-irradiation

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06344130

Conditions

Astrocytoma

Glioma

Recurrent Glioblastoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Study Details

Brief summary:

Background:

Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.

Objective:

To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.

Eligibility:

People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.

Design:

Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.

Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.

Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.

Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.

Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.

Conditions

Astrocytoma

Glioma

Recurrent Glioblastoma

Study ID

NCT06344130

Start date

Oct 1, 2024

Status verified date

Aug 12, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • 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 CRITERIA:

  • 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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1/Arm 1

Fraction size escalation of 3 planned re-irradiation dose levels.

experimental: 2/Arm 2

MTD of re-irradiation dose.

Interventions

Radiation Therapy

Radiation therapy will be administered via a linear accelerator using 6 megavoltage (MV) photons or greater.

Primary outcome measure

  • MTD of daily re-irradiation in participants with recurrent grade 4 gliomas [ Time Frame: DLT period (28 days) ]

Central Contacts and Locations

Central contacts

Rukayat O Salau

(240) 858-3712rukayat.salau@nih.gov

Peter GK Mathen, M.D.

(301) 496-5457peter.mathen@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 14, 2026

Last verified

Aug 12, 2026

Keywords

  • Radiotherapy
  • Hypofractionation
  • Re-irradiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-14.