Study on Azeliragon and Radiation Therapy for a Type of Brain Cancer Called Unmethylated Glioblastoma
Sponsor: Cantex Pharmaceuticals
ClinicalTrials ID:NCT05986851
This clinical trial is testing a new treatment using the drug azeliragon combined with radiation therapy for patients with a specific type of brain cancer known as unmethylated glioblastoma. The study aims to see if this combination is safe and can help control the cancer.
Patient Parameters
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Program Overview
This study is exploring a new treatment approach for patients with unmethylated glioblastoma, a fast-growing brain cancer that is difficult to treat. The trial will test the safety and effectiveness of combining azeliragon, a drug taken as a daily capsule, with radiation therapy. Azeliragon has shown promise in enhancing the effects of radiation and slowing cancer progression in early research. Participants will continue taking azeliragon even after completing radiation therapy.
Description
This clinical trial focuses on patients newly diagnosed with unmethylated glioblastoma, a type of brain cancer that does not respond well to the standard chemotherapy drug temozolomide. The study will combine azeliragon, a drug taken orally once a day, with radiation therapy to see if this combination can improve treatment outcomes. Azeliragon has been well tolerated in previous studies involving Alzheimer's patients and healthy volunteers.
Participants will receive azeliragon daily during and after radiation therapy. The study aims to determine if this approach can enhance the effectiveness of radiation and delay the progression of the disease. The trial is open to adults aged 18 and older who meet specific health criteria and have not received prior treatment for their glioblastoma.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with IDH-wildtype glioblastoma (GBM, WHO grade 4) confirmed by a biopsy or tumor removal surgery.
- Cancer must be located in the upper part of the brain (supratentorial location).
- Negative test for MGMT promoter methylation.
- Must have recovered from surgery and any related complications.
- Aged 18 years or older.
- Able to perform daily activities with some limitations (Karnofsky performance status of 60 or higher).
- Must have pre- and post-surgery MRI or CT scans of the brain.
- Treatment must start within 7 weeks after the most recent brain surgery.
- Adequate blood cell counts and organ function.
- If HIV positive, must be on effective treatment with undetectable viral load.
- If previously infected with hepatitis B or C, must have undetectable viral load.
- Women of childbearing potential must use effective birth control during the study.
- Must understand and agree to participate in the study by signing an informed consent form.
Exclusion Criteria
- History of another invasive cancer unless disease-free for 3 years.
- Previous radiation treatment to the head or neck.
- Prior use of certain brain cancer treatments like carmustine wafers.
- Recurrent or multiple separate tumors in the brain.
- Cancer located in the lower part of the brain or spread beyond the brain.
- Known IDH mutation.
- Serious active infections or medical conditions that could interfere with treatment.
- Conditions that prevent following the study protocol.
- Use of certain medications that interact with the study drug.
- Difficulty swallowing or absorbing oral medication.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial within 30 days before the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus | 80045 | Aurora | Colorado |
| Miami Cancer Institute - Baptist Health | 33176 | Miami | Florida |
| Corewell Health | 48073 | Royal Oak | Michigan |
| Washington University in St. Louis | 63110 | St Louis | Missouri |
| Lenox Hill Hospital | 10021 | New York | New York |
| The University of Oklahoma Health Science Center | 73104 | Oklahoma City | Oklahoma |
| University of Utah Health Huntsman Cancer Center | 84112 | Salt Lake City | Utah |
| University of Washington | 98109 | Seattle | Washington |
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