Triapine with Temozolomide for Recurrent Glioblastoma
This study is testing the safety and best dose of two medicines, triapine and temozolomide, for people with glioblastoma (a type of brain cancer) that has returned. Triapine works by stopping cancer cells from making DNA, which they need to grow. Temozolomide also damages cancer cell DNA to slow or stop their growth. Researchers hope that combining these two medicines will be safe and effective. This study is looking for about 30 participants. To join, you must have a specific type of glioma (brain tumor) that has returned, including glioblastoma, and be at least 18 years old. The main goal is to find the recommended dose of triapine when given with temozolomide.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of triapine to find the safest and most effective amount. It is not specified if this study is randomized or blinded.
- What's involved
- Participants will undergo blood sample collection, MRI scans, and may complete questionnaires. Some participants may also have surgery. Temozolomide will be taken by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for dose evaluation is measured at the end of Cycle 1 (28 days) plus 7 days.
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NCT06410248
Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~30 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMagnetic Resonance ImagingQuestionnaire AdministrationResectionTemozolomideTriapine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase 2 dose for triapine in combination with temozolomide
Measured over At the end of Cycle 1 (each cycle is 28 days) + 7 days (up to cycle 2 day 7)
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Karan Dixit, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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). Astrocytoma with molecular features of glioblastoma (GBM). Confirmed diagnosis via molecular testing
Patients must have an established diagnosis of recurrent glioblastoma and:
Group 1 and 2: recurrent glioblastoma
Group 3: Surgically amenable recurrent glioblastoma
Patients must have stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg dexamethasone, for ≥ 7 days prior to registration
Patients with disease that has progressed after a standard or investigational first-line therapy (e.g. radiotherapy \[RT\], RT plus temozolomide) with or without tumor treating fields therapy (TTFields)
Note: Patients who have received fractionated first-line radiation therapy and no prior chemotherapy (e.g. as common practice for MGMT unmethylated tumors), or who have participated in an investigational protocol substituting TMZ for a novel agent are eligible
Patients must be able to undergo contrast-enhanced magnetic resonance imaging (MRI)
Patients must be age ≥ 18 years
Patients must exhibit a Karnofsky performance status ≥ 70
Leukocytes (white blood cells \[WBC\]) ≥ 3,000/mcL
Absolute neutrophil count (ANC) ≥ 1,500/mcL
Hemoglobin (Hgb) ≥ 8 g/dL (transfusion may be used for eligibility outside of 7 days)
Platelets (PLT) ≥ 100,000/mcL (transfusion or growth factor may be used for eligibility outside of 7 days)
Total bilirubin ≤ 2 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 institutional ULN
International normalized ratio (INR) ≤ 1.5 x ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 x ULN
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 2B or better
Patients of child-bearing potential (POCBP) must agree to use two forms of adequate contraception (hormonal or barrier method of birth control, abstinence) from time of informed consent and for the duration of study participation. Patients who can impregnate their partners must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) from time of informed consent and for the duration of study participation
Should a patient become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.
Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)
Note: A POCBP is any person with an egg-producing reproductive tract (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) (in patients \> 45 years of age in the absence of other biological or physiological causes)
Potential POCBP who may be menopausal and are \< 55 years of age must have a serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL to confirm menopause
Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff
Patient must be willing and able to comply with the protocol for the duration of the study and provide written, signed, and dated informed consent prior to study registration.
NOTE: No study-specific screening procedures may be performed until written consent has been obtained
Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion
Patients who have a prior or concurrent malignancy that may interfere with study treatment or safety
NOTE: 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, per principal investigator (PI) discretion
Patients who are receiving any other investigational agents.
Exceptions: COVID-19 vaccine and treatment is allowed, per PI's discretion
Patient's interval since last cytotoxic therapy ≥ 1 cycle or ≥ 2 biological half-lives, i.e.
≥ 28 days since start of last cycle of temozolomide (cycle length-28 days)
≥ 42 days since start of last cycle of lomustine or other nitrosourea (cycle length-42 days)
≥ 21 days since start of last cycle of a small molecule targeted agent (cycle length-21 days)
≥ 42 days from last bevacizumab infusion (cycle length-42 days)
Patients who have a history of allergic reactions attributed to compounds of similar chemical composition to temozolomide or triapine
Patients with spinal cord and diffuse leptomeningeal dissemination
Patients with a history of G6PD deficiency or other congenital or autoimmune hemolytic disorders. All participants will be screened for G6PD levels prior to registration
Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
Have uncontrolled epilepsy
Have an uncontrolled intercurrent illness
Are pregnant or nursing
Concurrent malignancy (outside of glioblastoma) that requires tumor directed treatment
Known concurrent shingles, herpes, cytomegalovirus (CMV) infection
Known concurrent opportunistic fungal infection
Known immunodeficiency that could lead to opportunistic infections
Psychiatric illness/social situations that would limit compliance with study requirements
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Patients who are pregnant or nursing. Pregnant patients are excluded from this study because temozolomide is an alkylating agent with 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 temozolomide, breastfeeding should be discontinued if the mother is treated with temozolomide
Patients who are unable to swallow oral medication or have problems/diseases that affect absorption or oral medication
Patients with a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). If patient does not have a known history testing will not be conducted
Note: Temozolomide is an immunosuppressive agent. Patients with a known history of HIV, HBV, and HCV, and unexplained opportunistic infections are not eligible due to safety reasons
What this trial measures
- Recommended phase 2 dose for triapine in combination with temozolomideAt the end of Cycle 1 (each cycle is 28 days) + 7 days (up to cycle 2 day 7)
The recommended phase 2 dose will be based on treatment-emergent and drug-related toxicity. Dose limiting toxicities and adverse events (AEs) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0.