Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

Phase 2

Completed

• Conditions: Head and Neck Cancer; Precancerous/Nonmalignant Condition
• Interventions: Drug: Porfimer Sodium; Procedure: Photodynamic Therapy

• Registration Number: NCT00453336
• Lead Sponsor: University of Miami

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, precancerous cells and cancer cells are killed.

PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Detailed Description

OBJECTIVES:

* Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract.

* Determine the safety of this regimen in these patients.

OUTLINE: Patients are stratified according to disease condition (benign vs malignant).

Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4.

After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-28
• Primary Completion: 2009-08
• Study Completion: 2010-05
• Results First Submitted: 2013-08-14
• Results First Submitted QC: 2013-08-14
• Results First Posted: 2013-10-18
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Photodynamic Therapy	-
Single Arm	Porfimer Sodium	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	6 months	Number of participants enrolled experiencing serious adverse events and/or other non-serious events
Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment	6 months	Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami; 🇺🇸 Miami, Florida, United States