Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
I. Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding
in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell
carcinoma of the oral cavity.
II. Determine the spatial relationships between EF5 binding and various tumor tissue
markers, pathological processes, and serum plasminogen activator inhibitor-1 in these
III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors
in these patients.
IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal
measures of EF5 binding, patient/tumor characteristics, and biological markers in these
Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV
over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5
binding. Blood samples are analyzed for genetic markers and cytokines associated with
hypoxia and EF5 concentration.
Intervention Model: Single Group Assignment, Masking: Open Label
Time to locoregional recurrence in HNSCC patients
Time from study entry (EF5 administration) to locoregional recurrence, assessed up to 6 years
Stephen Michael Hahn
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|