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

• 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: University of Miami
• Information provided by (Responsible Party): University of Miami

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 (Clinical Trial)
• 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: June 2003
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: May 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 Name: 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 Name: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
   Number of participants enrolled experiencing serious adverse events and/or other non-serious events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

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

More Information

Publications of Results:

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.

• Responsible Party: University of Miami
• ClinicalTrials.gov Identifier: NCT00453336
• 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 Posted: March 28, 2007
• Results First Posted: October 18, 2013
• Last Update Posted: February 8, 2017
• Last Verified: December 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; Neoplasms; Dihematoporphyrin Ether; Trioxsalen; Antineoplastic Agents; Dermatologic Agents; Photosensitizing Agents