Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
Conditions
Head and Neck Cancer - Precancerous Condition
Conditions: official terms
Head and Neck Neoplasms - Precancerous Conditions
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Intervention
Name: aminolevulinic acid hydrochloride
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers - 800-474-9892
Start Date
January 2009
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page