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

NCT ID: NCT03034135

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2018-07-10

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.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DSF-Cu

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

Group Type: EXPERIMENTAL

Disulfiram/Copper

Intervention Type: DRUG

Disulfiram/copper gluconate is taken three times a day.

Temozolomide (TMZ)

Intervention Type: DRUG

TMZ is given per standard of care

Interventions

Disulfiram/Copper

Disulfiram/copper gluconate is taken three times a day.

Intervention Type: DRUG

Temozolomide (TMZ)

TMZ is given per standard of care

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantex Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiayi Huang, MD

Role: STUDY_CHAIR

Washington University School of Medicine in St. Louis

Locations

Beaumont Hospital

Royal Oak, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

Lenox Hill Hospital

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30771200 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CAN-201

Identifier Type: -

Identifier Source: org_study_id