Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

Criteria:

• Histologically confirmed oral leukoplakia with dysplasia OR oral leukoplakia with hyperplasia in a high-risk area (e.g., floor of mouth, tongue, or oropharynx)
• Multiple oral leukoplakia lesions are allowed however no more than 5 distinct lesions are biopsied and treated
• All lesions to be treated must be technically accessible by laser
• Patients with oral leukoplakia with hyperplasia in a non-high-risk location (e.g., buccal mucosa from ill-fitting dentures) are not allowed
• Must be willing to undergo baseline biopsies of leukoplakia lesion(s) and surrounding normal tissue 4-8 weeks before therapy and repeat biopsies at 3 months
• No evidence of ongoing radiation damage to the target site
• Karnofsky performance status (PS) 70-100% or Zubrod PS 0-1
• Life expectancy > 2 years
• Hemoglobin > 12 g/dL
• Platelet count > 100,000/mm^3
• ANC > 1,500/mm^3
• Creatinine =< 1.5 mg/dL
• SGPT and SGOT =< 1.5 x upper limit of normal (ULN)
• Total bilirubin =< 1.5 x ULN (a higher level of bilirubin due to a familial metabolism will be considered on an individual basis)
• Willing to adhere to avoidance of sunlight and indoor light exposure for 24 hours after treatment
• Not pregnant or nursing
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to aminolevulinic acid
• No porphyria
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness or social situation that, in the opinion of the investigators, would limit compliance or jeopardize the patient or integrity of the data
• Prior treatment for leukoplakia allowed
• No prior photodynamic therapy
• More than 3 months since prior participation in a clinical trial for leukoplakia
• More than 4 weeks since prior ablative therapy to the target lesion
• More than 4 weeks since prior and no concurrent psoralen or PUVA therapy
• No concurrent oral retinoids (e.g., isotretinoin)
• No concurrent use of tanning beds
• No other concurrent investigational agents
• Fertile patients must use effective contraception
• Patients with a previous diagnosis of stage I or II head and neck cancer are eligible provided definitive therapy, including radiation therapy, is completed and the patient has been rendered disease free for >= 2 years
• No chronic liver disease including those with normal liver function tests