Spots Global Cancer Trial Database for Photodynamic Therapy in Treating Patients With Lung Cancer

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Trial Identification

Brief Title: Photodynamic Therapy in Treating Patients With Lung Cancer

Official Title: 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

Study ID: NCT01668823

Conditions

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

Interventions

HPPH

photodynamic therapy

therapeutic bronchoscopy

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue toxicity using 2-\[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma. SECONDARY OBJECTIVES: I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or bronchogenic microinvasive carcinoma. OUTLINE: This is a dose-escalation study. Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5. After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and then periodically for at least 2 years.