Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
I. Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with
intra-abdominal malignancies or non-small cell lung cancer.
II. Determine the ratio of tumor to normal tissue by measuring the level of motexafin
lutetium uptake in tumor and normal tissue removed from these patients.
III. Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for
hypoxia) in tumors of these patients.
IV. Determine the feasibility of measuring optical properties, tissue oxygenation, motexafin
lutetium concentration, fluorescence, and blood flow by non-invasive means in these
OUTLINE: This is a multicenter, diagnostic study. Patients are stratified according to
diagnosis (intra-abdominal malignancy vs non-small cell lung cancer).
Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15
minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after
motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected
tumors are evaluated. Tumor to normal tissue ratios are also determined.
After completion of study treatment, patients are followed at approximately 1-8 weeks.
PROJECTED ACCRUAL: A total of 30 patients (20 with intra-abdominal malignancies and 10 with
non-small cell lung cancer) will be accrued for this study within 10-15 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Motexafin lutetium uptake in tumors and normal tissues
Data will be described using graphical techniques (e.g., box plots) and summary statistics (e.g., means, medians, standard deviations, and interquartile ranges). For each patient, the mean concentration of motexafin lutetium across tumor and normal samples will be summarized.
At the time 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|