Inclusion Criteria

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