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NCT06860594 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent Glioblastoma, IDH-Wildtype and Recurrent Astrocytoma, IDH-Mutant, Grade 4, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
20
Study locations

NCT06860594: Recruiting Phase 1 study of Recurrent Glioblastoma, IDH-Wildtype and Recurrent Astrocytoma, IDH-Mutant, Grade 4, sponsored by National Cancer Institute (NCI).

NCT06860594 is a Phase 1 study of Recurrent Glioblastoma, IDH-Wildtype and Recurrent Astrocytoma, IDH-Mutant, Grade 4 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 38-participant average among 4 other Recurrent Glioblastoma, IDH-Wildtype trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06860594, a Phase 1 study of Recurrent Glioblastoma, IDH-Wildtype and Recurrent Astrocytoma, IDH-Mutant, Grade 4, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Will be graded in severity according to the Common Terminology Criteria for Adverse Events version 5.0. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized with descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient and frequency tables will be reviewed to determine toxicity patterns. Will employ the Backfill Bayesian Optimal Interval design to guide dose escalation and establish the maximal tole

Conditions Studied

Recurrent Glioblastoma, IDH-Wildtype Recurrent Astrocytoma, IDH-Mutant, Grade 4 Astrocytoma, IDH-Mutant, Grade 2 Recurrent Astrocytoma, IDH-Mutant, Grade 3 Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant Recurrent Astrocytoma, IDH-Mutant

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • RADIATION Intensity-Modulated Radiation Therapy
  • DRUG Triapine

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • UM Sylvester Comprehensive Cancer Center at Doral - Doral
  • UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall - Miami
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia - North Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UC San Diego Moores Cancer Center - La Jolla
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • University of California Davis Comprehensive Cancer Center - Sacramento

Connecticut

  • Yale University - New Haven
  • Smilow Cancer Hospital Care Center-Trumbull - Trumbull

Illinois

  • Northwestern University - Chicago
  • Memorial Hospital East - Shiloh

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-07-30
Est. Completion 2027-06-30
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06860594 shows while recruiting

NCT06860594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 38-participant average among 4 other Recurrent Glioblastoma, IDH-Wildtype trials with a reported enrollment target (21% lower).

The record links to 7 conditions, with Recurrent Glioblastoma, IDH-Wildtype appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06860594 names 20 study sites across 6 states, led by Florida, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT06860594 about?

NCT06860594 is a clinical study titled "Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma". 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 e...

What is the current status of trial NCT06860594?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-07-30. Estimated completion is 2027-06-30.

What conditions does trial NCT06860594 study?

This clinical trial studies the following conditions: Recurrent Glioblastoma, IDH-Wildtype, Recurrent Astrocytoma, IDH-Mutant, Grade 4, Astrocytoma, IDH-Mutant, Grade 2, Recurrent Astrocytoma, IDH-Mutant, Grade 3, Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant.

What interventions are being tested in trial NCT06860594?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Intensity-Modulated Radiation Therapy (RADIATION), Triapine (DRUG).

Who is sponsoring clinical trial NCT06860594?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06860594 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06860594

Source: ClinicalTrials.gov NCT06860594, the US trial registry maintained by the National Library of Medicine. NCT06860594 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.