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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
OBJECTIVES: Primary To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions. Secondary To assess the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later. Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later. After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.

Official Title
-----------------
Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Conditions
-----------------
Head and Neck Cancer, Precancerous Condition

Intervention / Treatment
-----------------
* Drug: aminolevulinic acid hydrochloride


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later. | Drug: aminolevulinic acid hydrochloride<br>* Patients undergo continuous or fractionated photodynamic therapy.<br>|
| Experimental: Arm II<br>Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later. | Drug: aminolevulinic acid hydrochloride<br>* Patients undergo continuous or fractionated photodynamic therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity |  | One year | 
| Maximum tolerated dose |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | One year | 
| Duration of response |  | One year | 
| Time to progression |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
precancerous condition, stage 0 hypopharyngeal cancer, stage 0 laryngeal cancer, stage 0 lip and oral cavity cancer, stage 0 nasopharyngeal cancer, stage 0 oropharyngeal cancer, stage 0 paranasal sinus and nasal cavity cancer