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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

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

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aminolevulinic Acid

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