Is NCT06410248 recruiting in Chicago, IL?

Yes, NCT06410248 is currently recruiting participants at its Chicago, IL location. This recurrent glioblastoma, idh-wildtype clinical trial is actively enrolling qualified participants.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent Glioblastoma, IDH-Wildtype Clinical Trial in Chicago, IL

Q: How do I join the recurrent glioblastoma, idh-wildtype clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Recurrent Glioblastoma, IDH-Wildtype Study in Chicago

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.

Sponsor: Northwestern University

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT06410248) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Glioblastoma, IDH-Wildtype Treatment Options in Chicago, IL

If you're searching for recurrent glioblastoma, idh-wildtype treatment options in Chicago, IL, this clinical trial (NCT06410248) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent glioblastoma, idh-wildtype specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent glioblastoma, idh-wildtype clinical trials near you to find additional studies recruiting in your area.

Recurrent Glioblastoma, IDH-Wildtype Clinical Trial in Chicago, IL

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