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

Primary Purpose

Head and Neck Cancer, Precancerous/Nonmalignant Condition

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Porfimer Sodium
Photodynamic Therapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 27, 2007
Last Updated
December 14, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00453336
Brief Title
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Precancerous/Nonmalignant Condition
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Porfimer Sodium
Other Intervention Name(s)
Photofrin
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy
Other Intervention Name(s)
Microlens Diffuser P/N 5416
Intervention Description
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.
Primary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Civantos, Jr., MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23055220
Citation
Civantos F. Photodynamic therapy for head and neck lesions in the subtropics. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S65-8. doi: 10.6004/jnccn.2012.0179.
Results Reference
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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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