Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Biopsy confirmed carcinoma in situ (CIS) or microinvasive bronchogenic non-small cell lung carcinoma

• May have squamous cell carcinoma, adenocarcinoma, or large cell carcinoma histology

• Stage 0 (CIS or microinvasive) disease, meeting all of the following criteria:

• Lesion must be radiographically occult and not definable by conventional CT scan of the chest

• Lesion may or may not be invisible on white light bronchoscopy, but is definable and photographable on laser-induced fluorescence emission (LIFE) bronchoscopy

• Biopsy of the lesion must indicate no evidence of invasion beyond cartilage on histopathology, but may be invasive through the basement membrane (microinvasive carcinoma)

• No evidence of major pulmonary vessel encasement on CT scan of the chest

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2

• Platelet count ≥ 100,000/mm^3

• WBC ≥ 4,000/mm^3

• Prothrombin time ≤ 1.5 times upper limit of normal (ULN)

• Total bilirubin ≤ 3.0 mg/dL

• Creatinine ≤ 3.0 mg/dL

• Alkaline phosphatase (hepatic) or SGOT ≤ 3 times ULN

• 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 or partial central airway obstruction from mucous/debris formation

• Patients with underlying lung disease must be judged (by the principal investigator) able to withstand mucous or debris formation at the site of treatment

• No contraindications for bronchoscopy

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy

• Prior therapy of any type (e.g., chemotherapy or radiotherapy) allowed for lung cancer