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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Disulfiram is taken orally, twice daily.
Copper gluconate is taken orally, twice daily
Temozolomide is taken once daily
Aurora Health Care, Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
6 Months Progression Free Survival (PFS)
To determine 6 month PFS of patients with unmethylated glioblastoma treated with DSF-Cu in combination with concurrent radiation and temozolomide. This was assessed by the number of participants who did not have disease progression and were alive at 6 months.
Time frame: 6 months
Overall Survival
Overall Survival will be assessed as a number of participants alive at 1 and 2 years.
Time frame: 1 and 2 years
Quality of Life (QOL)
Edmonton Symptom Assessment System - Revised (ESAS-r) questionnaire
Time frame: 1 year
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