Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.
PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Tumor Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Photosensitizer (HPPH) Concentration in Tumor [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- STAT3 Cross-links as Assessed by Western Blotting [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Inflammation and Apoptosis as Assessed by Immunohistochemistry [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||March 2014|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
4 mg/m2 IVProcedure: endoscopic procedure
Treatment with 150 joules from laser
- 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 these patients.
- 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 treatment.
- 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 emission spectroscopy.
After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528775
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Todd L. Demmy, MD||Roswell Park Cancer Institute|