NCT03034135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 13, 2021

Completed
Last Updated

September 13, 2021

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

January 25, 2017

Results QC Date

April 2, 2021

Last Update Submit

August 17, 2021

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.

    6 months

Secondary Outcomes (5)

  • Progression Free Survival

    6 months

  • Overall Survival

    6 months and 12 months

  • Number of Participants With Serious Adverse Events

    14 months

  • Median Progression Free Survival

    12 months

  • Median Duration of Overall Survival

    14 months

Study Arms (1)

DSF-Cu

EXPERIMENTAL

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

Drug: Disulfiram/CopperDrug: Temozolomide (TMZ)

Interventions

Disulfiram/CopperDRUG

Disulfiram/copper gluconate is taken three times a day.

DSF-Cu
Temozolomide (TMZ)DRUG

TMZ is given per standard of care

DSF-Cu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37212, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

Related Publications (1)

  • 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.

    PMID: 30771200DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

disulfiram-copperTemozolomide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Stephen Marcus MD
Organization
Cantex Pharmaceuticals
smarcus@cantex.com
9543153660

Study Officials

  • Jiayi Huang, MD

    Washington University School of Medicine in St. Louis

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

March 9, 2017

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

September 13, 2021

Results First Posted

September 13, 2021

Record last verified: 2019-07

Locations

US(8)