Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer

Summary

Participation Requirements

Description

Inclusion criteria: Patients with stage IV breast cancer with metastases demonstrated by appropriate imaging techniques Histologically or cytologically confirmed tumor Age of 18 years or more Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 Patients have failed, untolerated or r...

Inclusion criteria: Patients with stage IV breast cancer with metastases demonstrated by appropriate imaging techniques Histologically or cytologically confirmed tumor Age of 18 years or more Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 Patients have failed, untolerated or refused standard therapeutic modalities Not received systemic anticancer therapy or radiation or had major surgery in last 2 weeks Not currently participating in another study Anticipated survival of at least 2 months Baseline aspartate aminotransferase (AST) and alanine aminotransferase (ALT) not greater than 2.5 X upper institutional limit Serum copper within normal limits Serum ceruloplasmin > 17 mg/dL Able and willing to sign informed consent and to comply with study procedures Able to ingest oral medications No known allergy to disulfiram or copper Willing to refrain from ingestion of alcoholic beverages while on the study Exclusion criteria: Participation in another clinical trial of a therapeutic drug during the past 14 days Addiction to alcohol or drugs Baseline AST or ALT greater than 2.5 X upper institutional limit Unable to ingest oral medications Unable to undergo CT/SPECT scanning because of inability to lie recumbent in the scanner Actively receiving cytotoxic cancer chemotherapy agents Anticipated survival of less than 2 months 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 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 History of Wilson's disease or family member with Wilson's disease History of hemochromatosis or family member with hemochromatosis History of other iron overload syndrome such as hemochromatosis Need for metronidazole, warfarin and/or theophylline medication, the metabolism of which is likely influenced by disulfiram Pregnant women and nursing mothers are not allowed to enroll on this study Patients who are taking medications metabolized by cytochrome P450 2E1, including chlorzoxazone or halothane and its derivatives

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