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Trial record 1 of 1 for:    03034135
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Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT03034135
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Cantex Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: Disulfiram/Copper Drug: Temozolomide (TMZ) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : July 10, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DSF-Cu
Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.
 Drug: Disulfiram/Copper
Disulfiram/copper gluconate is taken three times a day.

Drug: Temozolomide (TMZ)
TMZ is given per standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 6 months ]
    ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 months ]
    Percentage of patients that are free from progressive disease per RANO criteria

  2. Overall Survival [ Time Frame: 6 months and 12 months ]
    Percentage of patients that are alive

  3. Number of Participants With Serious Adverse Events [ Time Frame: 14 months ]
    Number of Participants with Grade 3 and 4 serious adverse events

  4. Median Progression Free Survival [ Time Frame: 12 months ]
    Duration of progression free survival according to RANO criteria

  5. Median Duration of Overall Survival [ Time Frame: 14 months ]
    Duration of overall survival for patients that are alive


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034135


Locations
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United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10075
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45220
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Sponsors and Collaborators
Cantex Pharmaceuticals
Investigators
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Study Chair: Jiayi Huang, MD Washington University School of Medicine in St. Louis
  Study Documents (Full-Text)

Documents provided by Cantex Pharmaceuticals:
Study Protocol and Statistical Analysis Plan  [PDF] May 28, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cantex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03034135    
Other Study ID Numbers: CAN-201
First Posted: January 27, 2017    Key Record Dates
Results First Posted: September 13, 2021
Last Update Posted: September 13, 2021
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Copper
Temozolomide
 Disulfiram
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trace Elements
Micronutrients
Physiological Effects of Drugs
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors