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

Abramson Cancer Center at Penn Medicine35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer Precancerous Condition

Interventions

aminolevulinic acid hydrochlorideDRUG

Patients undergo continuous or fractionated photodynamic therapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Dose-limiting toxicity

Time frame: One year

Maximum tolerated dose

Time frame: 90 days

Secondary Outcomes

Response rate

Time frame: One year

Duration of response

Time frame: One year

Time to progression

Time frame: 2 years

Data from ClinicalTrials.gov

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