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

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Precancerous Condition
• Intervention / Treatment: Drug: aminolevulinic acid hydrochloride

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicity	One year
Maximum tolerated dose	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to progression	2 years
Response rate	One year
Duration of response	One year

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Peter Ahn, MD, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimate): September 16, 2009

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: precancerous condition; stage 0 oropharyngeal cancer; stage 0 lip and oral cavity cancer; stage 0 laryngeal cancer; stage 0 hypopharyngeal cancer; stage 0 paranasal sinus and nasal cavity cancer; stage 0 nasopharyngeal cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Precancerous Conditions; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: CDR0000650536; UPCC-18308; IRB #809093