Primary Peritoneal Cavity Cancer Clinical Trial
Official title:
The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
This phase II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given
OBJECTIVES:
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
population.
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
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