Actively Recruiting
A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine Combined With Temozolomide for Patients With Recurrent Glioblastoma
Led by Northwestern University · Updated on 2026-05-01
30
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety, side effects, and best dose of triapine combined with temozolomide for patients with glioblastoma that has returned after a period of improvement. This phase I trial focuses on recurrent glioblastoma, including grades 2 to 4 gliomas that are IDH-wildtype. The study aims to determine the recommended phase 2 dose, assess safety, progression-free survival, overall survival, and response rate, as well as explore drug distribution, interactions, pharmacokinetics, and quality of life effects. Patients are assigned to one of three groups based on surgical plans. Groups 1 and 2 receive oral temozolomide once daily and oral triapine once daily on days 1 to 5 of each 28-day cycle, up to 6 cycles if there is no disease progression or unacceptable toxicity. Group 3 receives oral triapine for 5 days before surgical tumor removal, then begins the combined temozolomide and triapine treatment post-surgery under the same cycle schedule. All patients undergo MRI scans at screening and during the study and provide blood samples for analysis. Participants are closely monitored throughout the treatment cycles, with follow-up visits 30 days after treatment and then every 3 months for up to 24 months. Researchers will collect MRI data, blood samples, and quality of life questionnaires. They will evaluate the recommended dose, side effects, survival outcomes, and tumor response according to specific neuro-oncology criteria, ensuring patient safety and collecting detailed pharmacokinetic information during the study period.
CONDITIONS
Brief Title
Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed WHO grade 2-4 glioma that is IDH-wildtype or astrocytoma with molecular features of glioblastoma confirmed by molecular testing
- Established diagnosis of recurrent glioblastoma
- For Groups 1 and 2: recurrent glioblastoma without planned surgery
- For Group 3: surgically amenable recurrent glioblastoma
- Stable or decreasing corticosteroid dose equivalent to 6 mg dexamethasone or less for at least 7 days prior to registration
- Disease progression after standard or investigational first-line therapy, including radiotherapy with or without temozolomide
- Ability to undergo contrast-enhanced MRI
- Age 18 years or older
- Karnofsky performance status of 70 or higher
- Adequate blood counts and organ function within specified limits
- Clinical cardiac function assessment at class 2B or better if history of cardiac disease
- Agreement to use two forms of contraception if of child-bearing potential or to use adequate contraception if able to impregnate a partner
- Willingness and ability to comply with study protocol and provide informed consent
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with study treatment or safety, unless approved by the principal investigator
- Receiving other investigational agents except COVID-19 vaccine or treatment with investigator approval
- Insufficient time since last cytotoxic therapy or targeted agents as specified
- History of allergic reactions to compounds similar to temozolomide or triapine
- Spinal cord or diffuse leptomeningeal disease
- History of G6PD deficiency or hemolytic disorders
- Uncontrolled intercurrent illnesses including epilepsy, infections, immunodeficiency, psychiatric or social conditions limiting compliance
- Pregnant or nursing
- Unable to swallow oral medication or with absorption issues
- Known history of HIV, hepatitis B or C infections or unexplained opportunistic infections due to safety concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive oral triapine and temozolomide in cycles of 28 days. For participants not undergoing surgery, triapine and temozolomide are taken on days 1-5 of each cycle, repeated up to 6 cycles if there is no disease progression or unacceptable toxicity. For participants undergoing surgery, triapine is taken orally for 5 days before surgery, followed by temozolomide and triapine on days 1-5 of each 28-day cycle for up to 6 cycles in the absence of progression or toxicity. Participants also undergo MRI scans and blood sample collections during treatment.
Up to 6 treatment cycles with MRI and blood sample collection visits during treatment
Duration - Up to 24 months
After completing treatment, participants are followed up to monitor health status and survival. Follow-up visits occur 30 days after treatment ends and then every 3 months for up to 24 months.
Follow-up visits at 30 days post-treatment and every 3 months thereafter
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here