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

NCT ID: NCT00978081

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Head and Neck Cancer; Precancerous Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

aminolevulinic acid hydrochloride

Intervention Type: DRUG

Patients undergo continuous or fractionated photodynamic therapy.

Arm II

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

Group Type: EXPERIMENTAL

aminolevulinic acid hydrochloride

Intervention Type: DRUG

Patients undergo continuous or fractionated photodynamic therapy.

Interventions

aminolevulinic acid hydrochloride

Patients undergo continuous or fractionated photodynamic therapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://cancer.gov/clinicaltrials

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

Other Identifiers

UPCC-18308

Identifier Type: -

Identifier Source: secondary_id

IRB #809093

Identifier Type: -

Identifier Source: secondary_id

CDR0000650536

Identifier Type: -

Identifier Source: org_study_id

NCT01019954

Identifier Type: -

Identifier Source: nct_alias