Brain (Nervous System) CancersPhase 1NCT07719127
Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High Grade Glioma
A Phase 1 study testing Disulfiram (DSF) in people with Brain (Nervous System) Cancers, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain (Nervous System) Cancers
- What is being tested?
- Disulfiram (DSF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Window-of-Opportunity Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High-Grade Glioma
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.
Read the detailed description
Glioblastoma is one of the most common brain cancers that affect adults and is very hard to treat. This is due to myeloid cells, which are special immune cells in the body that prevent the body from recognizing and attacking the tumor. Because of this, immunotherapies have not worked well in treating glioblastoma.
Disulfiram may also reduce brain swelling, which may decrease or delay the need for subjects to be treated with steroids.
The purpose of this study is to find out if disulfiram can help reduce immunosuppression and help prevent edema symptoms when taken 3-14 days before planned surgery.
- Conditions
- Brain (Nervous System) Cancers
- Being tested
- Disulfiram (DSF)
- Keywords
- brain and nervous system
- Medical subject headings
- Neurologic Manifestations, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Disulfiram | Experimental | description here Receives: Drug: Disulfiram (DSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 0, up to 14 days
Secondary outcomes (6)
Proportion of participants needing dexamethasone within 48 hour window
Change in investigator-rated edema symptom composite score from baseline to Day 2 on therapy.
Measured: 48 hours
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
Measured: 14 days
Change in Edema Symptom Composite Score (ESCS)
Change in ESCS is analyzed using a Wilcoxon signed-rank test
Measured: day 0, up to 14 days
Tolerability of disulfiram
Tolerability as measured by participant toxicity rates.
Measured: 14 days
Change in Microglial Inflammatory program scores
Evaluate the change in microglial inflammatory 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.
Measured: day 0, up to 14 days
Change in Systemic Inflammatory Program Scores
Evaluate the change in systemic inflammatory 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.
Measured: day 0, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startOct 2026 (estimated)
- Primary completion17 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain (Nervous System) CancersStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Hodges, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719127
- Sponsor's protocol ID
- CASE7326
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie published results will be shared, as permitted by the informed consent, IRB approval, and institutional policy. This may include data dictionaries and de-identified clinical data elements needed to reproduce reported analyses, including eligibility and baseline characteristics, disulfiram exposure, dexamethasone/steroid exposure, edema-related symptom assessments, safety/adverse event data, and correlative assay-derived results from blood, tumor tissue, and CSF. Individual-level molecular, single-cell, spatial, or sequencing data will be shared only in de-identified and/or controlled-access form, as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window-of-Opportunity Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High-Grade Glioma
- ClinicalTrials.gov ID
- NCT07719127
- Acronym / sponsor ID
- CASE7326
- Conditions
- Brain (Nervous System) Cancers
- Keywords
- brain and nervous system
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 17 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glioblastoma is one of the most common brain cancers that affect adults and is very hard to treat. This is due to myeloid cells, which are special immune cells in the body that prevent the body from recognizing and attacking the tumor. Because of this, immunotherapies have not worked well in treating glioblastoma.
Disulfiram may also reduce brain swelling, which may decrease or delay the need for subjects to be treated with steroids.
The purpose of this study is to find out if disulfiram can help reduce immunosuppression and help prevent edema symptoms when taken 3-14 days before planned surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disulfiram | Experimental | Drug: Disulfiram (DSF)description here |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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%.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disulfiram (DSF)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. | Drug | Disulfiram |
Primary outcome
Reduction in Complement Immunosuppressive program
Time frame: day 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 program
Time frame: day 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.
6 secondary outcomes
Proportion of participants needing dexamethasone within 48 hour window
Time frame: 48 hours
Safety of disulfiram
Time frame: 14 days
Change in Edema Symptom Composite Score (ESCS)
Time frame: day 0, up to 14 days
Tolerability of disulfiram
Time frame: 14 days
Change in Microglial Inflammatory program scores
Time frame: day 0, up to 14 days
Change in Systemic Inflammatory Program Scores
Time frame: day 0, up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie published results will be shared, as permitted by the informed consent, IRB approval, and institutional policy. This may include data dictionaries and de-identified clinical data elements needed to reproduce reported analyses, including eligibility and baseline characteristics, disulfiram exposure, dexamethasone/steroid exposure, edema-related symptom assessments, safety/adverse event data, and correlative assay-derived results from blood, tumor tissue, and CSF. Individual-level molecular, single-cell, spatial, or sequencing data will be shared only in de-identified and/or controlled-access form, as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany Hodges, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Disulfiram (DSF) in people with Brain (Nervous System) Cancers, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Hodges, MD (216-286-7122, tiffany.hodges@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Complement Immunosuppressive program (time frame: day 0, up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.