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

Head and Neck Cancer Clinical Trial

Official title:

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978081
• Other study ID #: CDR0000650536
• Secondary ID: UPCC-18308IRB #8
• Status: Completed
• Phase: Phase 1
• Start date: January 2009
• Est. completion date: November 2016

Study information

• Verified date: April 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Drug:
• aminolevulinic acid hydrochloride
Patients undergo continuous or fractionated photodynamic therapy.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity		One year
Primary	Maximum tolerated dose		90 days
Secondary	Response rate		One year
Secondary	Duration of response		One year
Secondary	Time to progression		2 years

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database