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

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ClinicalTrials.gov Identifier: NCT00453336
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : October 18, 2013
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
University of Miami

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head and Neck Cancer
Precancerous/Nonmalignant Condition
Interventions Drug: Porfimer Sodium
Procedure: Photodynamic Therapy
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description

Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

Period Title: Overall Study
Started 45
Completed 45
Not Completed 0
Arm/Group Title Single Arm
Hide Arm/Group Description

Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  24.4%
>=65 years
34
  75.6%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
66
(30 to 92)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
23
  51.1%
Male
22
  48.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
Types of Lesions   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
Oral Cavity Lesions 24
Layngeal Lesions 18
Other Lesions 3
[1]
Measure Description: The types of lesions participants had at time of enrollment
Pathology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
Squamous Cell Carcinoma 22
Severe Dysplasia 13
Carcinoma in situ 9
Verrucous Carcinoma 1
1.Primary Outcome
Title Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
Hide Description Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
32
2.Primary Outcome
Title Number of Participants Experiencing Adverse Events
Hide Description Number of participants enrolled experiencing serious adverse events and/or other non-serious events
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:

Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: participants
36
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description

Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%) # Events
Total   24/45 (53.33%)    
General disorders   
Significant Postoperative Pain for Oral Lesions  23/45 (51.11%)  23
Respiratory, thoracic and mediastinal disorders   
Unfortunate Airway Disaster  1/45 (2.22%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm
Affected / at Risk (%) # Events
Total   12/45 (26.67%)    
Infections and infestations   
Temporary edema requiring tracheotomy  1/45 (2.22%)  1
Injury, poisoning and procedural complications   
Transient second-degree burn on the back of the hand  1/45 (2.22%)  1
Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders   
Mild Skin Irritation  8/45 (17.78%)  8
Surgical and medical procedures   
Transient Aspiration  1/45 (2.22%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Francisco Civantos MD
Organization: University of Miami Sylvester Comprehensive Cancer Center
Phone: 305-243-5276
Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00453336     History of Changes
Other Study ID Numbers: 20020618
SCCC-2002103 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20050715 ( Other Identifier: Western Institutional Review Board )
First Submitted: March 27, 2007
First Posted: March 28, 2007
Results First Submitted: August 14, 2013
Results First Posted: October 18, 2013
Last Update Posted: February 8, 2017