Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06410248

Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma

Led by Northwestern University · Updated on 2026-05-01

30

Participants Needed

1

Research Sites

302 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial tests the safety, side effects, and best dose of triapine in combination with temozolomide in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Triapine inhibits an enzyme responsible for producing molecules required for the production of deoxyribonucleic acid (DNA), which may inhibit tumor cell growth. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Giving triapine in combination with temozolomide may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma.

CONDITIONS

Official Title

Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed WHO grade 2-4 glioma, IDH wild type
  • Established diagnosis of recurrent glioblastoma
  • For groups 1 and 2: recurrent glioblastoma
  • For group 3: surgically amenable recurrent glioblastoma
  • Stable or decreasing corticosteroid dose equivalent to 64 6 mg dexamethasone for at least 7 days before registration
  • Disease progression after standard or investigational first-line therapy including radiotherapy with or without temozolomide
  • Able to undergo contrast-enhanced MRI
  • Age 18 years or older
  • Karnofsky performance status of 64 70
  • Leukocytes 64 3,000/mcL
  • Absolute neutrophil count 64 1,500/mcL
  • Hemoglobin 64 8 g/dL (transfusion allowed within 7 days)
  • Platelets 64 100,000/mcL (transfusion or growth factor allowed within 7 days)
  • Total bilirubin 64 2 times institutional upper limit of normal
  • AST/ALT 64 3 times institutional upper limit of normal
  • Creatinine 64 1.5 times institutional upper limit of normal
  • INR 64 1.5 times upper limit of normal
  • PT/PTT 64 1.5 times upper limit of normal
  • Cardiac function classified as New York Heart Association class 2B or better
  • Use of two forms of contraception if of child-bearing potential or agree to abstinence
  • Willing and able to comply with study protocol and provide informed consent
Not Eligible

You will not qualify if you...

  • Prior or concurrent malignancy that may interfere with study treatment or safety
  • Receiving other investigational agents (except COVID-19 vaccines or treatments as allowed)
  • Less than required time since last cytotoxic therapy (e.g., temozolomide, lomustine, targeted agents, bevacizumab)
  • History of allergic reactions to compounds similar to temozolomide or triapine
  • Spinal cord or diffuse leptomeningeal disease spread
  • History of G6PD deficiency or hemolytic disorders
  • Uncontrolled illness including epilepsy, infections, immunodeficiency, psychiatric illness, or other conditions limiting compliance or safety
  • Pregnant or nursing
  • Unable to swallow or absorb oral medication
  • Known history of HIV, hepatitis B, or hepatitis C infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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