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

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT00453336
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Duration (Months): 83
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Precancerous/Nonmalignant Condition	Drug: Porfimer Sodium; Procedure: Photodynamic Therapy	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Clinical Trial on the Efficacy of Photodynamic Therapy With Porfimer Sodium (Photofrin®) for Malignant and Pre-Malignant Lesions and Condemned Mucosa Syndrome in the Upper Aerodigestive Tract
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: 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.; Other Names: Photofrin ; Procedure: 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.; Other Names: Microlens Diffuser P/N 5416

Outcome Measures

Primary Outcome Measures

1. 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.

2. Number of Participants Experiencing Adverse Events [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Any of the following benign lesions:

• Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant

• Carcinoma in situ

• Superficial (< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx

• T1-T3 disease

• Meets one of the following criteria:

• Failed radiation therapy and refused standard salvage surgery

• Refused radiation therapy and/or surgery as primary therapy

• No good surgical alternative with acceptable morbidity

• Condemned mucosa syndrome

• At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas

PATIENT CHARACTERISTICS:

• Creatinine ≤ 2 mg/dL

• AST and ALT ≤ 30% elevated

• Alkaline phosphatase ≤ 30% elevated

• Bilirubin ≤ 1.0 mg/dL

• No contraindication to anesthesia or analgesia

• No porphyria

• No hypersensitivity to porphyrins

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Study Chair: Francisco Civantos, Jr., MD, University of Miami Sylvester Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Miami
• ClinicalTrials.gov Identifier: NCT00453336
• Other Study ID Numbers: 20020618; SCCC-2002103; WIRB-20050715
• First Posted: Mar 28, 2007
• Last Update Posted: Feb 8, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by University of Miami: recurrent squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; oral leukoplakia
• Additional relevant MeSH terms: Precancerous Conditions; Dihematoporphyrin Ether; Trioxsalen

Study Results

Participant Flow

Arm/Group Title	Single Arm
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

Baseline Characteristics

Arm/Group Title	Single Arm
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 Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 24.4%
>=65 years	34 75.6%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66
Gender (Count of Participants)
Female	23 51.1%
Male	22 48.9%
Region of Enrollment (participants) [Number]
United States	45 100%
Types of Lesions (participants) [Number]
Oral Cavity Lesions	24 53.3%
Layngeal Lesions	18 40%
Other Lesions	3 6.7%
Pathology (participants) [Number]
Squamous Cell Carcinoma	22 48.9%
Severe Dysplasia	13 28.9%
Carcinoma in situ	9 20%
Verrucous Carcinoma	1 2.2%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
Description	Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm
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.
Measure Participants	45
Number [participants]	32 71.1%

2. Primary Outcome

Title	Number of Participants Experiencing Adverse Events
Description	Number of participants enrolled experiencing serious adverse events and/or other non-serious events
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm
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.
Measure Participants	45
Number [participants]	36 80%

Adverse Events

Arm/Group Title	Single Arm
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	24/45 (53.3%)
General disorders
Significant Postoperative Pain for Oral Lesions	23/45 (51.1%)	23
Respiratory, thoracic and mediastinal disorders
Unfortunate Airway Disaster	1/45 (2.2%)	1
Other (Not Including Serious) Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	12/45 (26.7%)
Infections and infestations
Temporary edema requiring tracheotomy	1/45 (2.2%)	1
Injury, poisoning and procedural complications
Transient second-degree burn on the back of the hand	1/45 (2.2%)	1
Inflammatory Reaction from Extravasation of Porfimer Sodium at the Intravenous Site	1/45 (2.2%)	1
Skin and subcutaneous tissue disorders
Mild Skin Irritation	8/45 (17.8%)	8
Surgical and medical procedures
Transient Aspiration	1/45 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.