Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer

Launched by THE INSTITUTE OF MOLECULAR AND TRANSLATIONAL MEDICINE, CZECH REPUBLIC · Oct 25, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called disulfiram, combined with copper, as a possible new treatment for women with metastatic breast cancer. This means the cancer has spread beyond the breast to other areas of the body, and the goal is to see if this combination can help patients who have not responded to standard treatments or have found them too difficult to tolerate. The researchers will look at how well the treatment works by measuring how many patients show improvement in their condition, how long they remain stable, and their overall survival.

To participate in this trial, women must be at least 18 years old and have been diagnosed with stage IV breast cancer that has spread, confirmed by imaging tests. They should have tried or not been able to tolerate standard treatments and must not have had any major cancer treatments in the last two weeks. The trial is currently recruiting participants, and those who join can expect to receive the disulfiram and copper treatment while being monitored for safety and effectiveness. It is important to note that participants will need to avoid alcohol during the study and must be able to take medications by mouth.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with stage IV breast cancer with metastases demonstrated by appropriate imaging techniques (computer tomography - CT, positron emission tomography - PET or PET/CT, MRI, ultrasound, etc.)
• • 2. Histologically or cytologically confirmed tumor
• • 3. Age of 18 years or more
• • 4. ECOG performance status of 0 - 2
• • 5. Patients have failed, untolerated or refused standard therapeutic modalities
• • 6. Not received systemic anticancer therapy or radiation or had major surgery in last 2 weeks
• • 7. Not currently participating in another study
• • 8. Anticipated survival of at least 2 months
• • 9. Baseline AST and ALT not greater than 2.5 X upper institutional limit
• • 10. Serum copper within normal limits
• • 11. Serum ceruloplasmin \> 17 mg/dL
• • 12. Able and willing to sign informed consent and to comply with study procedures
• • 13. Able to ingest oral medications
• • 14. No known allergy to disulfiram or copper
• • 15. Willing to refrain from ingestion of alcoholic beverages while on the study
• Exclusion Criteria:
• • 1. Participation in another clinical trial of a therapeutic drug during the past 14 days
• • 2. Addiction to alcohol or drugs
• • 3. Baseline AST or ALT greater than 2.5 X upper institutional limit
• • 4. Unable to ingest oral medications
• • 5. Unable to undergo CT/SPECT scanning because of inability to lie recumbent in the scanner
• • 6. Actively receiving cytotoxic cancer chemotherapy agents
• • 7. Anticipated survival of less than 2 months
• • 8. Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative pregnancy test before enrollment
• • 9. History of active liver disease, including chronic active hepatitis, viral hepatitis (hepatitis B, C and CMV), cholestatic jaundice of any etiology, toxic hepatitis, or cholestatic hepatitis or jaundice with bilirubin greater than 2.0 X upper institutional limit
• • 10. History of Wilson's disease or family member with Wilson's disease
• • 11. History of hemochromatosis or family member with hemochromatosis
• • 12. History of other iron overload syndrome such as hemochromatosis
• • 13. Need for metronidazole, warfarin and/or theophylline medication, the metabolism of which is likely influenced by disulfiram
• • 14. Pregnant women and nursing mothers are not allowed to enroll on this study
• • 15. Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives