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Alkylating agents

Triapine + Temozolomide for Brain Tumors

Phase 1

Waitlist Available

Led By Karan Dixit, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed World Health Organization (WHO) grade 2-4 glioma, isocitrate dehydrogenase (IDH) wild type (WT) (by immunohistochemistry [IHC] R132H negative [neg] or sequencing) and astrocytoma with molecular features of glioblastoma (GBM) confirmed diagnosis via molecular testing

Patients must be age ≥ 18 years

Must not have

Patients with a known history of HIV, HBV, and/or HCV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of diagnosis until the patient initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause, assessed at 6, 12, and 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of using a drug called triapine alongside temozolomide to treat patients with recurrent glioblastoma. Triapine stops an enzyme that helps

Who is the study for?

This trial is for patients with recurrent glioblastoma, a type of brain tumor. Participants should have experienced an improvement period before the cancer returned. The study will involve various procedures including MRI scans and possibly surgery.

What is being tested?

The safety and optimal dosage of triapine in combination with temozolomide are being tested. Triapine may stop tumor growth by blocking DNA production, while temozolomide damages tumor cell DNA to potentially slow or stop the tumor's progression.

What are the potential side effects?

Possible side effects include those typical of chemotherapy such as nausea, fatigue, hair loss, and increased risk of infections due to lowered white blood cell counts. Specific side effects related to triapine could also occur but are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My glioma is WHO grade 2-4, IDH wild type, and has features of glioblastoma.

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I am 18 years old or older.

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I am mostly able to care for myself and carry out normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of HIV, HBV, or HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until the patient experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause, assessed at 6, 12, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until the patient experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause, assessed at 6, 12, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until the patient experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause, assessed at 6, 12, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended phase 2 dose for triapine in combination with temozolomide

Secondary study objectives

Incidence of AEs and serious AEs

Overall response rate (ORR)

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Groups 1 and 2 (temozolomide, triapine)Experimental Treatment5 Interventions

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.

Group II: Group 3 (triapine, surgical resection, temozolomide)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Temozolomide

2010

Completed Phase 3

~1880