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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma. To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients. Secondary To study tumor response in these patients. OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH at that time. After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and periodically thereafter.

Official Title
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A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDT using HPPH<br>Patients receive HPPH IV over 1 hour on day 1. Patients then receive photodynamic therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for endoscopic debridement on day 5. | Drug: HPPH<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as measured by NCI CTC v2.0 |  | Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response |  | At 4-6 weeks and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage 0 non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer