NCT06344130 Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
| NCT ID | NCT06344130 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Astrocytoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2024-10-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Peter GK Mathen, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT06344130 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Astrocytoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06344130 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06344130 currently recruiting?
Yes, NCT06344130 is actively recruiting participants. Contact the research team at theresa.cooleyzgela@nih.gov for enrollment information.
Where is the NCT06344130 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06344130 clinical trial?
NCT06344130 is sponsored by National Cancer Institute (NCI). The principal investigator is Peter GK Mathen, M.D. at National Cancer Institute (NCI). The trial plans to enroll 28 participants.