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|NCT03034135 : Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma|
|Ages||Min: 18 Years Max: N/A|
- Histologically confirmed GBM (WHO grade IV).
- The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the
planned start of treatment on this study UNLESS there is pathological verification of
recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent
- Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI)
[as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3
months from the last dose of TMZ.
- Karnofsky performance status (KPS) of at least 60%.
- Willing to remain abstinent from consuming alcohol.
- Recovered from the toxic effects of prior therapy to < grade 2 toxicity per NCI CTCAE
prior to study registration (except lymphopenia).
- Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin,
total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine
aminotransferase, BUN and creatinine.
- 11. Females of childbearing potential must be willing to use an acceptable method of
birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with
spermicide, or abstinence) for the duration of the study.
- Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri,
infratentorial tumor, or disease at sites remote from the supratentorial brain.
- Enrolled in another clinical trial testing a novel therapy or drug within the past 4
- Received more than one course of radiation therapy or more than a total dose of 75 Gy.
- History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.
- Treatment with the following medications are contraindicated with DSF: metronidazole,
isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline,
tindazole, tizanidine, atazanavir.
- Fever within 3 days prior to study enrollment.
- Active or severe hepatic or renal disease.
- Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
- History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to
glioblastoma, corticosteroid, or anti-epileptic medications.
- History of Wilson's disease.
- History of hemochromatosis.
- Pregnant or breastfeeding.
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