Active — Not RecruitingEarly Phase 1

Administration of Repurposed Ketoconazole in Glioma Patients

Indonesia80 participantsStarted 2023-02-28

Plain-language summary

This early phase 1 clinical trial tests whether ketoconazole, an antifungal drug, can penetrate primary glioma brain tumors through the blood-brain barrier at levels sufficient to disrupt tumor growth, based on preclinical studies targeting glucose metabolism. Gliomas, especially aggressive high-grade types (WHO grades III-IV), have limited treatments like surgery, radiation, or chemotherapy. Patients with low- or high-grade gliomas will receive single or repeated low doses of ketoconazole before scheduled surgery, tailored to their health and procedure timing. During surgery, drug levels will be measured in tumor tissue and plasma. Results will guide future trials exploring azole drugs as glioma therapies.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants aged 18 years or older. * Radiological confirmation of an intra-axial primary brain tumor (all grades) requiring surgical intervention. * Karnofsky Performance Status (KPS) of ≥60 and projected life expectancy exceeding 12 weeks. * Normal liver function, indicated by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 1.5x the upper limit of normal (ULN). * Normal renal function, defined as urea within 16.6-48.5 mg/dL, creatinine within 0.67-1.17 mg/dL, and/or eGFR ≥90 (within 1.5x the institutional ULN) . * Capacity to take oral medications. * Women of reproductive age and all male participants must commit to effective contraception (e.g., hormonal methods) throughout the trial. * Willingness and ability to provide written informed consent. * Commitment to adhere to the protocol, including treatment, procedures, and scheduled follow-ups. Exclusion Criteria: * Known hypersensitivity to ketoconazole. * Prior severe reactions (e.g., agranulocytosis, neutropenia) to ketoconazole or other azole antifungals used for parasitic conditions. * History of acute or chronic hepatitis. * Elevated liver enzymes (ALT, AST) or impaired renal function (urea, creatinine, eGFR) exceeding 1.5x ULN per local lab standards. * Current use of metronidazole without ability to switch to an alternative antibiotic at least 7 days prior to ketoconazole initiation. * Azole antifungal use within the preceding 3 months. * Pregnancy or breas…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is an early Phase 1 trial focused on measuring ketoconazole concentrations in tumor tissue versus the blood rather than testing whether it actually treats glioma, what does that mean for any potential benefit to me personally?
2Ketoconazole is a drug originally developed as an antifungal — what does my doctor think about the reasoning behind using it for glioma, and is there any early evidence that it can reach brain tumor tissue effectively?
3The trial is listed as 'active not recruiting,' which means it's already closed to new participants — are there similar pharmacokinetic or drug-penetration studies for glioma that I could still be considered for?
4Given that this study involves both low-grade (Grade I–II) and high-grade (Grade III–IV) gliomas, how would my specific grade and diagnosis affect whether a study like this would even be relevant to discuss for my situation?
5Before considering any experimental approach like this, should I be prioritizing standard-of-care treatment options first, and how would participation in a study like this fit around surgery, radiation, or chemotherapy?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in Ketoconazole Concentrations Between Tumor Tissue and Plasma in Primary All-Grade Gliomas

Timeframe: Preoperative administration to intraoperative sampling (4-120 hours post-dose)

Trial details

NCT IDNCT07585851

SponsorUniversitas Padjadjaran

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-25

View on ClinicalTrials.gov More Diffuse Glioma trials