Clinical trial for Recurrent Glioblastoma, IDH-Wildtype
Official title Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT06410248
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, being studied as a potential treatment for recurrent glioblastoma, idh-wildtype.
Also referred to as CCRG-81045, Gliotem.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn the safety, side‑effects, and best dose of triapine when given together with temozolomide in recurrent glioblastoma.
- Who it's for
- Adults who have a glioblastoma that has returned after previous treatment.
- What's involved
- Participants will receive triapine and temozolomide and will have regular medical visits and tests to monitor safety and side effects.
- Time commitment
- The trial runs for several months, with multiple clinic visits for dosing and monitoring.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically confirmed World Health Organization (WHO) grade 2-4 glioma, isocitrate dehydrogenase (IDH) wild type (WT) (by...
- 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 3 or fewer lines of prior therapy
You likely can't join if
- 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...
- 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 therapy ≥ 1 cycle or ≥ 2 biological half-lives, i.e.
- ≥ 28 days since start of last cycle of temozolomide (cycle length-28 days)
See the full eligibility criteria
Who can join
- 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).
- 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 3 or fewer lines of prior therapy
- Patients with a life expectancy of at least 3 months
- 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.
- 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
- Patients must have adequate organ and bone marrow function as defined below: Leukocytes (white blood cells [WBC]) ≥ 3,000/mcL, Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin (Hgb) ≥ 8 g/dL (transfusion may be...
- 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...
- 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...
- 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.
- 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...
- Potential POCBP who may be menopausal and are \ 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.
- Patients must have the ability to understand and the willingness to sign a written informed consent document
What rules you out
- 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 how well it works assessment of the investigational regimen are...
- 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 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 brainstem, spinal cord and diffuse leptomeningeal dissemination.
- Patients with gliomatosis or multifocal disease
- 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.