Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
Condition: Head and Neck Cancer; Precancerous/Nonmalignant Condition
MeSH terms: Precancerous Conditions
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Porfimer Sodium; Photodynamic Therapy
Intervention type(s): Drug; Procedure
Intervention description(s): 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.; 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 intervention name(s): Photofrin; Microlens Diffuser P/N 5416
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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