A Window-of-Opportunity Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High-Grade Glioma
Case Comprehensive Cancer Center
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.
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 sur…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDisulfiram (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.
Location
- University Hospitals Cleveland Medical CenterCleveland, Ohio