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Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

Study Purpose

This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03034135
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cantex Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jiayi Huang, MD
Principal Investigator Affiliation Washington University School of Medicine in St. Louis
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: DSF-Cu

Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.

Interventions

Drug: - Disulfiram/Copper

Disulfiram/copper gluconate is taken three times a day.

Drug: - Temozolomide (TMZ)

TMZ is given per standard of care

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Beaumont Hospital, Royal Oak, Michigan

Status

Address

Beaumont Hospital

Royal Oak, Michigan, 48073

Washington University School of Medicine, Saint Louis, Missouri

Status

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

John Theurer Cancer Center, Hackensack, New Jersey

Status

Address

John Theurer Cancer Center

Hackensack, New Jersey, 07601

Lenox Hill Hospital, New York, New York

Status

Address

Lenox Hill Hospital

New York, New York, 10075

University of Cincinnati, Cincinnati, Ohio

Status

Address

University of Cincinnati

Cincinnati, Ohio, 45220

Vanderbilt Ingram Cancer Center, Nashville, Tennessee

Status

Address

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37212

Baylor University Medical Center, Dallas, Texas

Status

Address

Baylor University Medical Center

Dallas, Texas, 75246

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550

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