Breast Cancer Clinical Trial
Official title:
Pilot Study to Characterize the HRHV Axis in the Microenvironment of Breast Cancers
Verified date | December 2012 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed Stage 0 - III invasive carcinoma of the breast - Tumor size greater than 1-cm by radiological (mammogram/ultrasound or MRI) evaluation - KPS status = 70 - Bilirubin = 1.5x normal - Creatinine = 1.8 - WBC > 3000/mm^3 and platelets > 100,000/mm^3 Exclusion Criteria: - Pregnant or breast-feeding women - Neoadjuvant chemo or hormonal therapy for existent breast malignancy - Allergy to IV contrast dye - History of grade III or IV peripheral neuropathy as defined by the NCI CTC - Previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Mark Dewhirst | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Dewhirst MW, Cao Y, Moeller B. Cycling hypoxia and free radicals regulate angiogenesis and radiotherapy response. Nat Rev Cancer. 2008 Jun;8(6):425-37. doi: 10.1038/nrc2397. Review. Erratum in: Nat Rev Cancer. 2008 Aug;8(8):654. — View Citation
Koch CJ, Hahn SM, Rockwell K Jr, Covey JM, McKenna WG, Evans SM. Pharmacokinetics of EF5 [2-(2-nitro-1-H-imidazol-1-yl)-N-(2,2,3,3,3-pentafluoropropyl) acetamide] in human patients: implications for hypoxia measurements in vivo by 2-nitroimidazoles. Cancer Chemother Pharmacol. 2001 Sep;48(3):177-87. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate tumor characteristics | 2 years | Yes | |
Secondary | Intra and Interpatient correlations with tumor hypoxia | 3 years | Yes |
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