RecruitingPhase 1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

United States30 participantsStarted 2025-07-30

Plain-language summary

This phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma or astrocytoma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including: * GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not) * Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not) * Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors. * Tumors ≤ 6 cm in maximal diameter. * Patients who had recent resection for recurrent tumor must have measurable disease. * Patients must have at least a 6-month break from last dose of radiation therapy. Re-irradiation within 6 months may increase risk for radiation necrosis/edema, which will affect toxicity assessment and patient safety. Additionally, GBM and other high-grade astrocytic tumors can exhibit pseudo-progression within 6 months from completing definitive, 1st line radiation therapy, and re-irradiation during this period will increase risk for misattribution of effect. * Prior history of standard dose radiation for gliomas of 59.4-60 gray (Gy) in 1.8-2 Gy per fraction (or equivalent or lower) is allowed. * Patients who received non-standard radiation dose regimen (e.g., 40 Gy, 34-35 Gy, 25 Gy) or stereotactic radiosurgery are eligible as long as there is at least one of the following: * A new tumor outside the original radiotherapy field as determined by the investigator. * There is histologic confirmation of tumor on biopsy or resection. * Imaging findings …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial primarily focused on finding safe doses of Triapine combined with radiation, what does that mean for what's actually known right now about whether it helps people with recurrent glioblastoma or astrocytoma — and how does that affect your recommendation for me specifically?
2The trial is measuring dose-limiting toxicity as its main goal, so what kinds of side effects from Triapine are researchers most concerned about, and how would those interact with the radiation therapy I'd already be receiving?
3My tumor has specific molecular features — like IDH mutation status or H3 mutation status — and this trial covers several different tumor types; does my particular diagnosis make me a closer or more distant fit for what this study is designed to study?
4Since this trial involves recurrent disease, would you recommend I consider any standard salvage treatments first before a Phase 1 study, or is the standard-of-care landscape limited enough at this stage that a trial like this makes sense to explore sooner?
5What would the treatment schedule actually look like in terms of how often I'd need to come in for radiation and Triapine, and is that realistic given my current health and day-to-day life?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of dose-limiting toxicity

Timeframe: Up to 28 days

Trial details

NCT IDNCT06860594

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Astrocytoma, IDH-Mutant, Grade 2 trials