Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed diagnosis of 1 of the following within the past 3 months:
• •* Erythroplakia with dysplasia
• •* Severe dysplasia
• •* Carcinoma in situ of the head and neck for which standard therapy is not indicated, according to any of the following:
• •* Medical condition that precludes surgery
• •* Lesions that cannot be completely resected based on size or location
• •* Significant functional morbidity would be anticipated with further surgery
• •* Refused standard therapy after the treatment has been discussed and offered
• •No invasive squamous cell carcinoma of the head and neck
• •PATIENT CHARACTERISTICS:
• •ECOG performance status of 0-2
• •Platelet count ≥ 100,000/mm\^3
• •Total bilirubin ≤ 2 times upper limit of normal (ULN)
• •AST or ALT ≤ 2 times ULN
• •Alkaline phosphatase ≤ 2 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior chronic liver disease or cirrhosis of the liver
• •No porphyria or hypersensitivity to porphyrins
• •No significant cardiovascular history that, in the opinion of a cardiologist, would deem the patient at risk for hypotension that may occur with oral administration of aminolevulinic acid (Levulan®)
• •No prior adverse reaction to ondansetron or lorazepam
• •PRIOR CONCURRENT THERAPY:
• •Not specified