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
Intervention: Porfimer Sodium; Photodynamic Therapy
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.; 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.
Intervention MeSH terms: Dihematoporphyrin Ether; Trioxsalen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

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