An Early Phase 1 interventional study of EF5 and Partial or Total Mastectomy in Breast Cancer, sponsored by Mark Dewhirst. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-17.
Sponsored by Mark Dewhirst · Early Phase 1, Interventional, and Diagnostic
The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.
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Single arm study analyzing tumor hypoxia after EF5 injection
Drug: EF5 · Procedure: Partial or Total Mastectomy
An infusion of EF5, a fluorinated 2-nitroimidazole, will be administered using the recommended dose of 21mg/kg one day prior to surgical procedure.
A small tissue sample will be removed from the excised tissue and will be stored for later analysis.
To evaluate tumor characteristics
Time frame: 2 years
Intra and Interpatient correlations with tumor hypoxia
Time frame: 3 years
This study is withdrawn, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Mark Dewhirst