Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
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
Study Phase
Phase 1
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Name: aminolevulinic acid hydrochloride
Type: Drug
Overall Status
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


- 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.


- 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

- 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


- 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


- Not specified
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
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Record processing date processed this data on July 28, 2015 page