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

Phase 1

Completed

• Conditions: Head and Neck Cancer; Precancerous Condition
• Interventions: Drug: aminolevulinic acid hydrochloride

• Registration Number: NCT00978081
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	aminolevulinic acid hydrochloride	Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
Arm II	aminolevulinic acid hydrochloride	Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	One year
Maximum tolerated dose	90 days

Secondary Outcome Measures

Name	Time	Method
Response rate	One year
Duration of response	One year
Time to progression	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States