Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03034135 : Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- 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
TMZ.

- 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.

Exclusion Criteria:

- 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
weeks.

- 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.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03034135      |      Link to official Clinicaltrials.gov listing
Locations
Royal Oak, Michigan
Facility: Beaumont Hospital
Investigator:
Contact: Melissa Wienczewski, RN Phone: 248-551-0736
Click HERE to send email to this center

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator:
Contact: Jiayi Huang, MD Phone: 314-747-8567
Click HERE to send email to this center

Hackensack, New Jersey
Facility: John Theurer Cancer Center
Investigator:
Contact: Lori Capello Phone: 551-996-5098
Click HERE to send email to this center

New York, New York
Facility: Lenox Hill Hospital
Investigator:
Contact: Tamika Wong Phone: 212-434-4836
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Cincinnati, Ohio
Facility: University of Cincinnati
Investigator:
Contact: Rekha Chaudhary, MD Phone: 513-569-5286
Click HERE to send email to this center

Nashville, Tennessee
Facility: Vanderbilt Ingram Cancer Center
Investigator:
Contact: Kaye Delfino Phone: 800-811-8480
Click HERE to send email to this center

Dallas, Texas
Facility: Baylor University Medical Center
Investigator:
Contact: Karen Fink, MD Phone: 214-818-8472
Click HERE to send email to this center

Salt Lake City, Utah
Facility: Huntsman Cancer Institute
Investigator:
Contact: Measom Emily Phone: 801-585-0431
Click HERE to send email to this center




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