Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma
NCT ID: NCT06860594
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-07-30
2027-06-30
Brief Summary
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Detailed Description
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I. To identify the safety and maximally tolerated dose (MTD) of oral triapine used in combination with radiation therapy for patients with recurrent glioblastoma (GBM) or astrocytoma.
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To determine the pharmacokinetics of oral triapine in plasma and the central nervous system (CNS).
III. To evaluate the efficacy of triapine when administered in combination with radiation therapy by assessing:
IIIa. Progression-free survival (PFS); IIIb. Overall survival (OS); IIIc. The proportion of patients requiring bevacizumab for symptom control; IIId. The correlation of genetic mutations in select genes (e.g., p53, p16, KRAS, and Pi3k/mTOR/AKT) with tumor response and clinical outcomes.
OUTLINE: This is a dose-escalation study of triapine in combination with radiation therapy.
Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days per week (Monday-Friday) for a total of 10 treatment days over 2 weeks and receive triapine orally (PO) 2 hours prior to IMRT on each radiation treatment day in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study as well as blood sample collection during screening and on study. Patients may undergo cerebrospinal fluid (CSF) sample collection during screening.
After completion of study treatment, patients are followed up at 2 weeks after radiation therapy, then every 3 months for up to 5 years from study treatment initiation.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (IMRT, triapine)
Patients undergo IMRT QD 5 days per week (Monday-Friday) for a total of 10 treatment days over 2 weeks and receive triapine PO 2 hours prior to IMRT on each radiation treatment day in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study as well as blood sample collection during screening and on study. Patients may undergo CSF sample collection during screening.
Biospecimen Collection
Undergo blood and CSF sample collection
Computed Tomography
Undergo CT
Intensity-Modulated Radiation Therapy
Undergo IMRT
Magnetic Resonance Imaging
Undergo MRI
Triapine
Given PO
Interventions
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Biospecimen Collection
Undergo blood and CSF sample collection
Computed Tomography
Undergo CT
Intensity-Modulated Radiation Therapy
Undergo IMRT
Magnetic Resonance Imaging
Undergo MRI
Triapine
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Stephanie M Yoon
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center LAO
Locations
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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
Northwestern University
Chicago, 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
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 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
Countries
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Facility Contacts
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Other Identifiers
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NCI-2025-01531
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHI-151
Identifier Type: -
Identifier Source: secondary_id
10699
Identifier Type: OTHER
Identifier Source: secondary_id
10699
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2025-01531
Identifier Type: -
Identifier Source: org_study_id