The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
I. Determine the level of hypoxia through etanidazole derivative EF5 binding in patients
with intraperitoneal or pleural malignancies treated with photodynamic therapy.
II. Determine the microvascular density in this patient population. III. Determine the
relationships between levels of hypoxia, measures of microvascular density, and
photosensitizer levels in this patient population.
IV. Correlate hypoxia and photosensitizer levels with clinical outcome in this patient
V. Determine the toxic effects of EF5 in this patient population.
OUTLINE: This is a multicenter study.
Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after
EF5 administration, patients with intraperitoneal tumors undergo surgical resection.
Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5
administration. Tumors are then analyzed for EF5 binding and microvascular density by
immunohistochemistry and fluorescent antibody techniques.
Patients are followed at 2 weeks and at 30-45 days post EF5 infusion.
PROJECTED ACCRUAL: A total of 80 patients (50 with intraperitoneal malignancy and 30 with
pleural malignancy) will be accrued for this study within 2.5 years. Patients are stratified
by disease (intraperitoneal malignancy vs pleural malignancy).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Level of hypoxia in tumor nodules
Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients.
At the completion of surgery
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|