Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies the side effects and best dose of photodynamic therapy using aminolevulinic acid in treating patients with oral leukoplakia. Photodynamic therapy uses a drug, such as aminolevulinic acid, that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using aminolevulinic acid may be effective against oral leukoplakia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aminolevulinic Acid

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