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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06860594

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Biospecimen Collection (Procedure)
    Undergo blood and CSF sample collection
  • Computed Tomography (Procedure)
    Undergo CT
  • Intensity-Modulated Radiation Therapy (Radiation)
    Undergo IMRT
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Triapine (Drug)
    Given PO

Eligibility criteria

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.

Conditions

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 Glioblastoma, IDH-Wildtype

Locations

  • City of Hope Comprehensive Cancer Center — Duarte, California, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
  • University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
  • Yale University — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
  • MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Springs — Coral Springs, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Hollywood — Hollywood, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Memorial Hospital East — Shiloh, Illinois, United States
  • University of Kansas Clinical Research Center — Fairway, Kansas, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
  • Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record