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Experimental drug triapine paired with radiation targets recurrent brain cancers

NCT ID NCT06860594

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 12 times

Summary

This early-phase trial tests the safety and best dose of the drug triapine when given together with radiation therapy for people whose glioblastoma or astrocytoma has come back. Triapine works by blocking enzymes that cancer cells need to grow, while radiation kills cancer cells directly. The study will enroll 30 adults and aims to find the highest safe dose and check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Triapine
What this could lead to
If this works, it could point toward a new treatment option for people with recurrent brain tumors that have few choices.
What could go wrong
This is a very early, small phase I trial focused on safety and dosing, not yet on effectiveness. It may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 are consistent with true progressive disease (on standard MRI sequences, MRI spectroscopy/perfusion, or nuclear medicine imaging). * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of triapine in patients \< 18 years of age, children are excluded from this study. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). * Absolute neutrophil count ≥ 1,500/mcL. * Hemoglobin ≥ 8 g/dL. * Platelets ≥ 100,000/mcL. * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional ULN. * Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better. * Patients must be able to swallow whole capsules. * Patients must be able to undergo MRIs with contrast. Patients with non-compatible devices with MRI can be eligible if CT scans of sufficient quality are obtained. However, patients without non-compatible devices may not use CT scans to meet this requirement. * The effects of triapine on the developing human fetus are unknown. For this reason and because ribonucleotide reductase (RNR) inhibitor agent and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after finishing study treatment. People of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 2 weeks of registration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of triapine administration. * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia. * Patients who are receiving any other investigational agents. * Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials \[primaquine, chloroquine\], cyclophosphamide, and ifosfamide). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine. * Patients with known G6PD deficiency. Testing for G6PD deficiency is not required. * Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous. * Pregnant women are excluded from this study because triapine is a RNR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine. These potential risks may also apply to the radiation used in this study.

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Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) astrocytoma, IDH-mutant, grade 2 astrocytoma, IDH-mutant, grade 3 astrocytoma, IDH-mutant, grade 4 diffuse glioma, H3 G34 mutant diffuse intrinsic pontine glioma diffuse midline glioma, H3 K27M-mutant follicular lymphoma glioblastoma IDH-wildtype glioblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Astrocytoma, IDH-mutant, grade 2 Recurrent adult diffuse hemispheric glioma, H3 G34-mutant Recurrent adult diffuse midline glioma, H3 K27-mutant Recurrent astrocytoma, IDH-mutant Recurrent astrocytoma, IDH-mutant, grade 3 Recurrent astrocytoma, IDH-mutant, grade 4 Recurrent diffuse midline glioma Recurrent glioblastoma, IDH-wildtype

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    37 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

  • MedStar Georgetown University Hospital

    SUSPENDED

    Washington D.C., District of Columbia, 20007, United States

  • Memorial Hospital East

    ACTIVE_NOT_RECRUITING

    Shiloh, Illinois, 62269, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

    Contact Email: •••••@•••••

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Siteman Cancer Center at Christian Hospital

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    ACTIVE_NOT_RECRUITING

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    ACTIVE_NOT_RECRUITING

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63129, United States

  • Smilow Cancer Hospital Care Center-Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

    Contact Email: •••••@•••••

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

    Contact Email: •••••@•••••

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Doral

    RECRUITING

    Doral, Florida, 33166, United States

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    RECRUITING

    Hollywood, Florida, 33021, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    RECRUITING

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Clinical Research Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    RECRUITING

    North Miami, Florida, 33181, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    SUSPENDED

    Richmond, Virginia, 23298, United States

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.