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

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 1

Conditions: Precancerous Condition; Head and Neck Cancer

Treatments: Drug: aminolevulinic acid hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00978081

CDR0000650536

IRB #809093

UPCC-18308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.

Treatment:

Drug: aminolevulinic acid hydrochloride

Arm II

Experimental group

Description:

Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

Treatment:

Drug: aminolevulinic acid hydrochloride