TABLE 2.
Summary of clinical trials using disulfiram for cancer treatment.
| Study Title | Tumour Type | Drugs | Dose | Status | Outcome | Identifier |
|---|---|---|---|---|---|---|
| Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer | Breast cancer (Metastatic) | Disulfiram/Copper Supplement | DSF: 400 mg p.o./d Cu: 2 mg p.o./d | Phase II, Recruiting | N/A | NCT03323346 |
| Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer | Breast Cancer (Refractory, HER2-VE) | Vinorelbine, Cisplatin, Disulfiram, Copper | DSF: 400 mg p.o./d Cu: 2 mg p.o./d | Phase II, Recruiting | N/A | NCT04265274 |
| Disulfiram and Cisplatin in Refractory TGCTs | Germ cell tumour | Disulfiram, Cisplatin | DSF: 400 mg p.o./d | Phase II, Recruiting | N/A | NCT03950830 |
| Disulfiram in Treating Patients With Glioblastoma Multiforme After Radiation Therapy With Temozolomide | Glioblastoma | Disulfiram/Copper, Gluconate, Temozolomide | DSF: 500 mg p.o./d; Cu: 6 mg p.o./d | Early Phase I, Completed | Max. tolerated dose = 500 mg/day | NCT01907165 |
| Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme | Glioblastoma | Disulfiram/Copper Gluconate Temozolomide | DSF 125 mg p.o./twice daily; Cu: 2 mg p.o./twice daily | Phase II, Recruiting | N/A | NCT03363659 |
| Disulfiram/Copper Combination In The Treatment of Newly Diagnosed Glioblastoma Multiform | Glioblastoma | Disulfiram/Copper Temozolomide | N/A | Phase II, Not Yet Recruiting | N/A | NCT01777919 |
| Disulfiram in Recurrent Glioblastoma | Glioblastoma | Disulfiram/Copper Temozolomide | DSF 400 mg p.o./d; Cu: 2 mg p.o./d | Phase II/III, Completed | N/A | NCT02678975 |
| Bioavailability of Disulfiram and Metformin in Glioblastomas | Glioblastoma | Disulfiram, Metformin | DSF: 200 mg p.o./twice/d Cu: 2.5 mg p.o./d | Early Phase I, Terminated | N/A | NCT03151772 |
| Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma | Glioblastoma | Disulfiram/Copper Gluconate | DSF: 125 mg, 250 mg, 375 mg or 500 mg p.p./d | Phase I/II, Recruiting | Low toxicity at 250 mg/day. Median follow-up of 12.3 mo, 1-yr PFS: 57%; 1-yr OS: 69% | NCT02715609 |
| Cu: 2 mg p.o./thrice daily | ||||||
| Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma | Glioblastoma (recurrent) | Disulfiram/Copper, Temozolamide | DSF/Cu: 80 mg p.o./thrice daily | Phase II, Completed | Low toxicity (1/23 with grade 3 elevated ALT); ORR 0/23; 14% with clinical benefit | NCT03034135 |
| A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by nine Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma | Glioblastoma (recurrent) | Disulfiram Metronomic Temozolamide | 250 mg p.o./d; 250 mg p.o. twice daily | Phase I, Active Not Recruiting | N/A | NCT02770378 |
| Disulfiram and Chelated Zinc for the Rx of Disseminated Mets Mel That Has Failed First Line Therapy | Melanoma | Disulfiram and Zinc | N/A | Phase II, Completed | 1 grade 3+ toxicity (confusional episode); ORR 0/12; 1 target lesion –27% | NCT02101008 |
| Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy | Melanoma (Metastatic) | Disulfiram | 250 mg p.o. twice daily | Phase I, Terminated | N/A | NCT00571116 |
| Disulfiram in Patients With Metastatic Melanoma | Melanoma (Stage IV) | Disulfiram | 250 mg p.o. twice daily, escalated until maximum tolerated dose | Phase I/II, Completed | N/A | NCT00256230 |
| Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma | Multiple Myeloma (Refractory) | Disulfiram, Copper Gluconate | N/A | Phase 1, Recruiting | N/A | NCT04521335 |
| Initial Assessment of the Effect of the Addition of Disulfiram (Antabuse) to Standard Chemotherapy in Lung Cancer | Non-Small Cell lung Cancer | Disulfiram, Chemotherapy | N/A | PhaseII/III, completed | Benefit in PFS (5.9 vs 4.9 mo) and OS (10.0 vs 7.1 mo) | NCT00312819 |
| Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine | Pancreatic Cancer (Metastatic) | Disulfiram/Copper Gluconate | N/A | Phase II, Recruiting | N/A | NCT03714555 |
| Disulfiram and Chemotherapy in Treating Patients With Refractory Solid Tumors or Metastatic Pancreatic Cancer | Pancreatic Cancer (Metastatic, Recurrent) | Disulfiram, Gemcitabine | 250 mg p.o./d, 28 days | Phase I, Recruiting | N/A | NCT02671890 |
| A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer | Prostate Cancer (Metastatic Castrate-resistant) | Disulfiram/Copper Gluconate | DSF: 80 mg p.o./three times daily; Cu: 1, 3, 5, or 7 mg on cycle 1 days 1, 8, and 15 | Phase I, Terminated | No grade > 3 toxicities; no effect on PSA; 64Cu-PET shows Cu-uptake in some metastases | NCT02963051 |
| Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA) | Prostate Cancer (Recurrent) | Disulfiram | 250 mg p.o./d, 28 days; 500 mg p.o./d, 28 days | Completed | Moderate tolerability (6/19 with grade 3); 5/19 (26%) patients with change in 5-methyl-cytosine; no effect on PSA levels | NCT01118741 |
| Phase I Study of Disulfiram and Copper Gluconate for the Treatment of Refractory Solid Tumors Involving the Liver | Solid Cancer (Refractory, liver) | Disulfiram/Copper Gluconate | DSF: 250 mg p.o./d Cu: 2 mg p.o./d | Phase I, Completed | Well tolerated; no dose limiting toxicity; one stable disease | NCT00742911 |