Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme (NCT03363659) | Clinical Trial Compass
TerminatedPhase 2
Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme
Stopped: Investigator decision
United States15 participantsStarted 2018-03-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age 18 or older
* Diagnosis of histologically confirmed glioblastoma (WHO grade IV). Subjects with an original histologic diagnosis of low grade glioma or anaplastic glioma (WHO grade II or III) are eligible if a subsequent histological diagnosis of glioblastoma is made
* Patients whose tumor is determined to be unmethylated
* Patients with incomplete resection as determined by residual, measurable gadolinium or contrast-enhancing lesion or lesions
* Recent resection of glioblastoma within 4 weeks of study entry. Patients who have only had a tumor biopsy and who are considered unresectable are eligible (but based on the study accrual this subset of patients with unresectable tumor may be considered for separate analysis)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤ 2 (see appendix A)
* Willing to remain abstinent from consuming alcohol while on DSF
* No prior radiation or chemotherapy
* Meets the following laboratory criteria:
* Absolute neutrophil count ≥ 1,500/mcL (microliter)
* Platelets ≥ 100,000/mcL
* Hemoglobin \> 10.0 g/dL (grams/deciliter) (transfusion and/or ESA (erythropoiesis-stimulating agent) allowed)
* Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
* Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
* Able to take oral medication
* Able to understand and willing to sign an inst…