Photodynamic Therapy in Treating Patients With Lung Cancer

Completed · Phase 1

Conditions studied: Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage 0 Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01668823

Run by

Roswell Park Cancer Institute

People needed

17

Starts

2004-02-01

Expected to finish

2014-06-01

Last updated by the study team

2014-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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