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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00978081

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Precancerous Condition	Drug: aminolevulinic acid hydrochloride	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm I

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

Drug: aminolevulinic acid hydrochloride

Patients undergo continuous or fractionated photodynamic therapy.

Experimental: Arm II

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

Drug: aminolevulinic acid hydrochloride

Patients undergo continuous or fractionated photodynamic therapy.

Outcome Measures

Primary Outcome Measures

Dose-limiting toxicity [One year]
Maximum tolerated dose [90 days]

Secondary Outcome Measures

Response rate [One year]
Duration of response [One year]
Time to progression [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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