NCT03363659

Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme

A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients With Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

One of Disulfiram antitumor effects suggested in preclinical studies is MGMT (methyl-guanine-methyl-transferase) inhibition. Disulfiram MGMT inhibitory effect is enhanced by addition of Copper. This study evaluates the impact of Disulfiram (DSF) + Copper (Cu) combination when added to standard Temozolomide in the treatment of unmethylated Glioblastoma Multiforme (GBM) patients.

Detailed description

Glioblastoma is the most common malignant primary brain tumor and one of the most devastating cancers. The current standard of care for glioblastoma includes maximal safe resection followed by radiotherapy and temozolomide, which results in a median progression-free survival of less than 7 months, and median overall survival (OS) of less than 15 months. Moreover, patients with unmethylated glioblastoma respond poorly to this current standard treatment. This clinical trial evaluates the potential role of continuous, upfront use of Disulfiram in combination with Copper gluconate in enhancing temozolomide effect in the treatment of unmethylated Glioblastoma multiforme (GBM) patients.

Conditions

• Glioblastoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Disulfiram	Disulfiram is taken orally, twice daily.
DIETARY_SUPPLEMENT	Copper gluconate	Copper gluconate is taken orally, twice daily
DRUG	Temozolomide	Temozolomide is taken once daily

Timeline

• Start date: 2018-03-28
• Primary completion: 2022-01-13
• Completion: 2022-01-13
• First posted: 2017-12-06
• Last updated: 2024-10-03
• Results posted: 2023-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study