A Phase II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Advanced Obstructing Endobronchial Lung Cancer
- To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with
advanced obstructing endobronchial non-small cell lung cancer.
- To determine palliation of symptoms in patients treated with this regimen.
- To determine the amount of HPPH taken up by the obstructing endobronchial tumors in
- To determine the extent of STAT3 cross-links, which are molecular markers of immediate
PDT reaction, in the obstructing tumors of these patients before and after PDT
- To determine inflammation and apoptosis in the obstructing bronchial tumors of these
patients before and after PDT treatment.
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo
photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers
passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement
on day 5. If viable tumor is found outside of the initial treatment area, patients may
receive another dose of laser light without additional HPPH.
Patients may undergo tumor biopsies periodically during study for optional
biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by
western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and
other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence
After completion of study treatment, patients are followed at 4-6 weeks and then
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Todd L. Demmy, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|