This research study is for participants with glioblastoma. It can cause a tumor immunosuppression which helps myeloid cells that can stop T-cell function. Disulfiram is a drug that has been used in treating other disorders, but this study will examine if disulfiram can help make the tumor environment less immunosuppressive and reduce brain swelling when taken before surgery.
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.
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.
Single group
Disulfiram (DSF)
Drug250 milligrams (mg) disulfiram will be given daily for 3-14 prior to operation. Participants can have the option to be treated at 500mg after initial evaluation.
Reduction in Complement Immunosuppressive program
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 program
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.
Proportion of participants needing dexamethasone within 48 hour window
Change in investigator-rated edema symptom composite score from baseline to Day 2 on therapy.
Safety of disulfiram
Safety is defined as the rates of adverse events experienced by participants. Adverse event severity is graded according to the NCI Common Terminology for Adverse Events (CTCAE) Version 5.0
Change in Edema Symptom Composite Score (ESCS)
Change in ESCS is analyzed using a Wilcoxon signed-rank test
Tolerability of disulfiram
Tolerability as measured by participant toxicity rates.
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This trial is not recruiting at the moment. You can still explore other options:
