A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study

Inclusion Criteria:

- Patients with biopsy confirmed carcinoma-in-situ (CIS) or microinvasive lung cancer

- Patients may have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma

- Patients may have received prior therapy for lung cancer of any type, e.g.
chemotherapy, radiation therapy

- Patients must have no contraindications for bronchoscopy

- Female patients must not be pregnant and must be practicing a medically acceptable
form of birth control, be sterile or post-menopausal

- Patients must have a Karnofsky scale 50 or above (Eastern Cooperative Oncology Group
[ECOG] 0-2)

- Patients must sign an Informed Consent according to Food and Drug Administration
(FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional
Review Board (IRB)

- Patients with underlying lung disease must be judged (by the principal investigator)
able to with stand mucous/debris formation at the site of treatment

- Definition of CIS or microinvasive lung cancer for this protocol: the lesion will be
radiographically occult and not definable by conventional computed tomography (CT) of
the chest; the lesion may or may not be invisible on white light bronchoscopy, but is
definable and photographable on lung imaging fluorescence endoscope (LIFE)
bronchoscopy; biopsies of the lesion must indicate no evidence of invasion beyond
cartilage on histopathology; the lesion may, however, be invasive through the
basement membrane (microinvasive carcinoma)

Exclusion Criteria:

- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

- White blood cells (WBC) < 4000

- Platelet count < 100,000

- Prothrombin time exceeding 1.5 times the upper normal limit

- Total serum bilirubin > 3.0 mg/dl

- Serum creatinine > 3.0 mg/dl

- Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3
times the upper normal limit

- Severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the
investigator preclude multiple bronchoscopies or partial central airway obstruction
from mucous/debris formation

- Any evidence of worsening pulmonary symptoms or COPD exacerbation

- Evidence of major pulmonary vessel encasement on CT scan of the chest

- Myocardial infarction (Ml) or unstable angina in the previous 6 months