Trial Outcomes & Findings for Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract (NCT NCT00453336)

Last Updated: 2017-02-08

Results Overview

Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

6 months

Results posted on

2017-02-08

Participant milestones
Measure	Single Arm 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 Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Single Arm n=45 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Gender Female	23 Participants n=5 Participants
Gender Male	22 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Types of Lesions Oral Cavity Lesions	24 participants n=5 Participants
Types of Lesions Layngeal Lesions	18 participants n=5 Participants
Types of Lesions Other Lesions	3 participants n=5 Participants
Pathology Squamous Cell Carcinoma	22 participants n=5 Participants
Pathology Severe Dysplasia	13 participants n=5 Participants
Pathology Carcinoma in situ	9 participants n=5 Participants
Pathology Verrucous Carcinoma	1 participants n=5 Participants

Timeframe: 6 months

Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.

Outcome measures
Measure	Single Arm n=45 Participants 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.
Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment	32 participants

Timeframe: 6 months

Number of participants enrolled experiencing serious adverse events and/or other non-serious events

Outcome measures
Measure	Single Arm n=45 Participants 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.
Number of Participants Experiencing Adverse Events	36 participants

Serious events: 24 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events
Measure	Single Arm n=45 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Unfortunate Airway Disaster	2.2% 1/45 • Number of events 1
General disorders Significant Postoperative Pain for Oral Lesions	51.1% 23/45 • Number of events 23

Other adverse events
Measure	Single Arm n=45 participants at risk 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.
Skin and subcutaneous tissue disorders Mild Skin Irritation	17.8% 8/45 • Number of events 8
Injury, poisoning and procedural complications Transient second-degree burn on the back of the hand	2.2% 1/45 • Number of events 1
Injury, poisoning and procedural complications Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site	2.2% 1/45 • Number of events 1
Surgical and medical procedures Transient Aspiration	2.2% 1/45 • Number of events 1
Infections and infestations Temporary edema requiring tracheotomy	2.2% 1/45 • Number of events 1

University of Miami Sylvester Comprehensive Cancer Center

Phone: 305-243-5276