Trials / Completed
CompletedNCT02678975
Disulfiram in Recurrent Glioblastoma
DIRECT (DIsulfiram REsponse as add-on to ChemoTherapy in Recurrent) Glioblastoma: A Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Sahlgrenska University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical data to support disulfiram as an anticancer agent. The potency of disulfiram as an anticancer agent seems strengthened by copper. The investigators aim is to investigate disulfiram and copper-supplement as add-on treatment in glioblastoma patients with recurrence receiving alkylating chemotherapy.
Detailed description
Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical data to support disulfiram as an anticancer agent. The potency of disulfiram as an anticancer agent seems strengthened by copper. There is now anecdotal clinical evidence of disulfiram as an anticancer agent. So far no clinical studies have been published in glioma patients, but two small, uncontrolled studies are planned according to clinicaltrials.gov. with search 1st November 2015. The investigators aim to investigate disulfiram and copper-supplement as add-on treatment in glioblastoma patients with recurrence receiving alkylating chemotherapy. The study will be performed as a multicenter RCT including patients in Norway and Sweden. This will serve as a proof-of concept study. The primary end-point is survival at 6 months
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Disulfiram | Disulfiram 400 mg daily |
| DIETARY_SUPPLEMENT | Copper | nutritional supplement with copper, 2 mg daily |
| DRUG | Alkylating Agents | Alkylating antineoplastic agent |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2021-01-15
- Completion
- 2021-01-15
- First posted
- 2016-02-10
- Last updated
- 2021-03-18
Locations
8 sites across 2 countries: Norway, Sweden
Source: ClinicalTrials.gov record NCT02678975. Inclusion in this directory is not an endorsement.