Disulfiram for High-Grade Glioma Before Surgery

This research study is for people with high-grade glioma (a type of brain cancer) who are planning to have surgery. The study is looking at whether a drug called disulfiram (DSF) can make the tumor environment less able to suppress the immune system and reduce brain swelling. Disulfiram is given daily for 3 to 14 days before your operation. Researchers will measure changes in your immune system's response to the tumor during this time. The study aims to enroll 20 participants who are at least 18 years old and have a good performance status (Karnofsky Performance Status of 70% or higher).

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would take disulfiram daily for 3 to 14 days before your planned surgery. You would also need to be an in-patient for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, which measure immune system changes, are assessed at day 0 and up to 14 days.

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NCT07719127

Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High Grade Glioma

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~20 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Disulfiram (DSF)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in Complement Immunosuppressive program
Measured over day 0, up to 14 days
+1 more outcome measured
Brain (Nervous System) Cancers
1 sites across 1 states
Ohio1
  • Tiffany Hodges, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Reduction in Complement Immunosuppressive programday 0, up to 14 days

    Evaluate whether disulfiram given pre-operation reduces the Complement Immunosuppressive myeloid program scores vs historical controls, which will be compared using a two-sample Wilcoxon rank-sum test (primary) and a two-sample t-test on the participant-level program scores (sensitivity). Measured using scRNA-sequence data.

  • Reduction in Scavenger Immunosuppressive programday 0, up to 14 days

    Evaluate whether disulfiram given pre-operation reduces the Scavenger Immunosuppressive myeloid program scores vs historical controls, which will be compared using a two-sample Wilcoxon rank-sum test (primary) and a two-sample t-test on the participant-level program scores (sensitivity). Measured using scRNA-sequence data.