Photodynamic Therapy in Treating Patients With Lung Cancer

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with lung cancer. 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, cancer cells are killed.

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

Details

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

Criteria

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