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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
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Cantex Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Objective Response Rate [ Time Frame: 6 months ]
The percentage of patients with Complete Response or Partial Response according to the RANO criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03034135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Progression Free Survival [ Time Frame: 6 months ]
    Proportion of patients that are free from progressive disease
  • Overall Survival [ Time Frame: 2 years ]
    Proportion of patients that are alive
  • Toxicity [ Time Frame: 6 months ]
    Adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma
Official Title  ICMJE A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE
  • Drug: Disulfiram/Copper
    Disulfiram/copper gluconate is taken three times a day.
  • Drug: Temozolomide (TMZ)
    TMZ is given per standard of care
Study Arms  ICMJE 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
  • Drug: Temozolomide (TMZ)
Publications * Huang J, Chaudhary R, Cohen AL, Fink K, Goldlust S, Boockvar J, Chinnaiyan P, Wan L, Marcus S, Campian JL. A multicenter phase II study of temozolomide plus disulfiram and copper for recurrent temozolomide-resistant glioblastoma. J Neurooncol. 2019 May;142(3):537-544. doi: 10.1007/s11060-019-03125-y. Epub 2019 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
20
Actual Study Completion Date  ICMJE July 10, 2018
Actual Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034135
Other Study ID Numbers  ICMJE CAN-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cantex Pharmaceuticals
Study Sponsor  ICMJE Cantex Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jiayi Huang, MD Washington University School of Medicine in St. Louis
PRS Account Cantex Pharmaceuticals
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP