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

NCT07719127 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CASE7326
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain (Nervous System) Cancers

Keywords

brain and nervous system

Outcome Measures

Primary Outcomes (2)

• 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.

  day 0, up to 14 days

• 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.

  day 0, up to 14 days

Secondary Outcomes (6)

• Proportion of participants needing dexamethasone within 48 hour window

  48 hours

• Safety of disulfiram

  14 days

• Change in Edema Symptom Composite Score (ESCS)

  day 0, up to 14 days

• Tolerability of disulfiram

  14 days

• Change in Microglial Inflammatory program scores

  day 0, up to 14 days

Study Arms (1)

Disulfiram

EXPERIMENTAL

description here

Drug: Disulfiram (DSF)

Interventions

Disulfiram (DSF) DRUG

250 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.

Disulfiram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Neurologic Manifestations; Neoplasms

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Tiffany Hodges, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Hodges, MD

CONTACT

216-286-7122; tiffany.hodges@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data supporting published results will be made available beginning after publication of the primary results and completion of institutional review for data release. Data will remain available for at least 3 years after publication, or longer if required by repository, journal, sponsor, or institutional policy.
• Access Criteria: Access will be provided to qualified investigators for scientifically and ethically appropriate research uses, after review and approval of a written request, execution of any required data use agreement, and confirmation that the proposed use is consistent with the informed consent, IRB approval, and institutional policies. Controlled-access data will not include direct identifiers.

Locations

US (1)