Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

Study Overview
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Brief Summary
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RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, precancerous cells and cancer cells are killed. PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Detailed Description
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OBJECTIVES: Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract. Determine the safety of this regimen in these patients. OUTLINE: Patients are stratified according to disease condition (benign vs malignant). Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4. After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Official Title
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A Phase II Clinical Trial on the Efficacy of Photodynamic Therapy With Porfimer Sodium (Photofrin®) for Malignant and Pre-Malignant Lesions and Condemned Mucosa Syndrome in the Upper Aerodigestive Tract

Conditions
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Head and Neck Cancer, Precancerous/Nonmalignant Condition

Intervention / Treatment
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* Drug: Porfimer Sodium
* Procedure: Photodynamic Therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Any of the following benign lesions: Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant Carcinoma in situ Superficial (< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx T1-T3 disease Meets one of the following criteria: Failed radiation therapy and refused standard salvage surgery Refused radiation therapy and/or surgery as primary therapy No good surgical alternative with acceptable morbidity Condemned mucosa syndrome At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas PATIENT CHARACTERISTICS: Creatinine ≤ 2 mg/dL AST and ALT ≤ 30% elevated Alkaline phosphatase ≤ 30% elevated Bilirubin ≤ 1.0 mg/dL No contraindication to anesthesia or analgesia No porphyria No hypersensitivity to porphyrins Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics

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: Single Arm<br> | Drug: Porfimer Sodium<br>* Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.<br>* Other names: Photofrin;Procedure: Photodynamic Therapy<br>* Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.<br>* Other names: Microlens Diffuser P/N 5416;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment | Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0. | 6 months | 
| Number of Participants Experiencing Adverse Events | Number of participants enrolled experiencing serious adverse events and/or other non-serious events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, oral leukoplakia