Status and phase
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About
This clinical trial studies disulfiram in treating patients with glioblastoma multiforme (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diagnosis of histologically confirmed GBM (WHO grade IV).
At least 18 years of age.
ECOG performance status of at least 2.
Has received or is in the process of completing a course of definitive radiotherapy of at least 45 Gy with concurrent temozolomide (patient may be registered before completing radiotherapy as long as it is anticipated that s/he will complete at least 45 Gy).
Eligible for and planning to receive maintenance temozolomide after completion of definitive radiotherapy plus temozolomide.
Willing to remain abstinent from consuming alcohol while on disulfiram.
Meets the following laboratory criteria:
Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to take oral medication.
Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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