A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer
Status:
Terminated
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the safety and optimal dosing of intravenous copper
chloride and disulfiram in men with metastatic castrate-resistant prostate cancer (CRPC).
Eligible men will have neuroendocrine prostate cancer (NEPC), adenocarcinoma CRPC with
non-liver/peritoneal metastases (lymph nodes, bone, or lung) or adenocarcinoma CRPC with
liver and/or peritoneal metastases. Subjects will receive three doses of intravenous copper
chloride and take disulfiram and oral copper gluconate until disease progression (up to two
years). Subjects will also undergo a PET scan with radioactive copper 64 to measure the
levels of copper in their tumor. The central hypotheses of this project are that (a) copper
chloride and disulfiram are safe to give together and that (b) the combination of disulfiram
with copper will have efficacy for both mCRPC and NEPC.
Phase:
Phase 1
Details
Lead Sponsor:
Daniel George, MD
Collaborators:
Cantex Pharmaceuticals Give 1 For Dad Campaign Peter Michael Foundation The V Foundation for Cancer Research