Lung Cancer Clinical Trial
Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages
Summary
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.
Full Description
OBJECTIVES:
Primary
To determine the efficacy of photodynamic therapy (PDT) using HPPH in patients with advanced obstructing endobronchial non-small cell lung cancer.
Secondary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Biopsy confirmed advanced obstructing endobronchial non-small cell lung cancer
May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology
Ineligible for or refused surgical resection
Local endobronchial recurrence after prior surgical resection, radiotherapy, or chemotherapy allowed
No evidence of tumor encasement of major pulmonary vessels on CT scan of the chest
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
WBC ≥ 4,000/mm³
Platelet count ≥ 100,000/mm³
Prothrombin time < 1.5 times upper limit of normal (ULN)
Total bilirubin ≤ 2.0 mg/dL
Creatinine ≤ 2.0 mg/dL
Alkaline phosphatase (hepatic) ≤ 3 times ULN
SGOT ≤ 3 times ULN
No contraindications for bronchoscopy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after the completion of study treatment
Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous/debris formation at the site of treatment
Patients who cannot breathe due to complete upper airway obstruction and who need emergency treatment to open the airway are not eligible
No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
No severe chronic obstructive pulmonary disease that, in the opinion of the investigator, would preclude multiple bronchoscopies
No partial central airway obstruction from mucous/debris formation
No high-grade upper airway obstruction of the trachea
PRIOR CONCURRENT THERAPY:
Any type of prior therapy (e.g., chemotherapy or radiotherapy) for lung cancer allowed
At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy
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There is 1 Location for this study
Buffalo New York, 14263, United States
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