Can an old alcohol-dependence drug help the immune system fight brain cancer?
NCT ID NCT07719127
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether disulfiram, a drug long used for alcohol dependence, can reduce immune suppression caused by high-grade gliomas. Participants take disulfiram for 3 to 14 days before their scheduled tumor-removal surgery. The goal is to see if the drug can dampen the tumor's ability to block immune cells and lessen brain swelling, potentially reducing the need for steroids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- disulfiram, a drug used for alcohol dependence, repurposed to target immune suppression in brain tumors
- What this could lead to
- If successful, this could point toward a way to make brain tumors more responsive to the immune system and reduce reliance on steroids.
- What could go wrong
- This is a very early phase 1 trial with only 20 participants, so results may not apply broadly. Disulfiram may not effectively alter the tumor environment or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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: * Age ≥18 years. * Radiographically suspected or confirmed high-grade glioma planned for surgical resection as part of standard clinical care. * Able to start disulfiram at least 3 days prior to planned surgery (treatment window 3-14 days pre-op). * In-patient status for the duration of study. * Karnofsky Performance Status (KPS) ≥70%. * Adequate organ function within 14 days prior to first dose: * ANC ≥1.5 x 10\^9/L * Platelets ≥100 x 10\^9/L * Hemoglobin ≥9 g/dL * AST/ALT ≤2.5 x ULN * Total bilirubin ≤1.5 x ULN (unless Gilbert syndrome, in which case \<5 x ULN). * Total bilirubin ≤1.5 x ULN (unless Gilbert syndrome, in which case \<5 x ULN). * Ability to understand and willingness to sign written informed consent. * Willingness to avoid alcohol and alcohol-containing products during treatment and for 14 days after last dose. Exclusion Criteria: * Any dexamethasone (or other systemic glucocorticoid for cerebral edema) administered prior to enrollment/first dose (including outpatient or ED administration). This does not include inhalers or topical steroids. * Imaging features that are atypical for high-grade glioma that have reasonable concern for competing differential diagnoses (e.g. PCNSL, tumefactive MS, etc.) * Known hypersensitivity to disulfiram or thiuram derivatives. * Active or severe hepatic disease (e.g. hepatitis, cirrhosis, known liver disease that may be exacerbated by disulfiram), or baseline liver tests above inclusion thresholds. * Current use of metronidazole or other contraindicated interacting medications. See section 6.0; medication reconciliation for the list of medications/foods. * Pregnant or breastfeeding. Pregnant women are excluded from the trial because the safety in pregnancy has not been established. Women who are breastfeeding are excluded from the trial because it is not known if disulfiram is present in breast milk. * Clinically unstable neurologic status requiring immediate steroid initiation, where delaying dexamethasone for a disulfiram trial would be unsafe (investigator judgment). * Any condition that would limit compliance with alcohol avoidance or study procedures, or that would make participation unsafe in investigator judgment. * Subjects receiving any other investigational agents. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled or unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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