Can a common antifungal drug help fight brain cancer? new study investigates
NCT ID NCT07585851
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether ketoconazole, a drug normally used for fungal infections, can get into brain tumors (gliomas) in enough amounts to possibly slow their growth. About 80 adults with different grades of glioma will take low doses of the drug before their scheduled surgery. Researchers will measure drug levels in the tumor tissue and blood to see if it crosses the blood-brain barrier, which could lead to future studies using similar drugs for glioma treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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80 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 breastfeeding. * Any coexisting medical, psychiatric, or lab abnormality that, per investigator judgment, heightens study risks or confounds data interpretation. * Unavailability for follow-up or inability to fulfill protocol demands. * Concurrent use of ketoconazole metabolic inducers (e.g., isoniazid, nevirapine, rifampin, rifabutin) without discontinuation option.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Brain Center Hospital Prof. Dr. dr. Mahar Mardjono
Jakarta, Jakarta Special Capital Region, 13630, Indonesia
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Other studies related to the condition(s) this trial covers.
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