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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06410248
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent Glioblastoma, IDH-Wildtype
  • Recurrent WHO Grade 2 Glioma
  • Recurrent WHO Grade 3 Glioma
  • Recurrent WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Resection — PROCEDURE
    Undergo surgical resection
  • Temozolomide — DRUG
    Given PO
  • Triapine — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Apr 2026
Primary completion
May 12, 2029
Completion
May 12, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 3 (triapine, surgical resection, temozolomide)
    Patients receive triapine PO QD for 5 days prior to surgical resection. After surgical resection, patients receive temozolomide PO QD and triapine PO QD on days 1-5 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI at screening and on study and undergo collection of blood samples on study.
  • Experimental: Groups 1 and 2 (temozolomide, triapine)
    Patients receive temozolomide PO QD and triapine PO QD on days 1-5 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI at screening and on study and undergo collection of blood samples on study.

Primary Outcome Measure

Recommended phase 2 dose for triapine in combination with temozolomide [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) + 7 days (up to cycle 2 day 7) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Karan Dixit
[email protected]
312-503-1818
Karan Dixit (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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