Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Condition: Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Tongue Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Verrucous; Squamous Cell Carcinoma of Head and Neck; Recurrence
Intervention: Laboratory Biomarker Analysis; Photodynamic Therapy; Porfimer Sodium
Intervention description: Correlative studies; Undergo image-guided I-PDT; Given IV
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: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the effects of interstitial photodynamic therapy in patients with
      head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination
      of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During
      treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may
      be an effective treatment for head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

          -  Histologically confirmed recurrent squamous cell carcinoma of the oral cavity,
             pharynx, (oropharynx, larynx) and neck

          -  Tumor accessible for unrestricted illumination for interstitial photodynamic therapy
             (PDT) (accessibility as determined by the physician)

          -  Patients on chemotherapy &/or targeted agents for palliation

          -  Life expectancy of at least 6 months in the judgment of the physician

          -  Subjects of child-bearing potential must agree to use adequate contraceptive methods
             (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry
             and for 6 months after the last treatment; should a woman become pregnant or suspect
             she is pregnant while she or her partner is participating in this study, she should
             inform her treating physician immediately

          -  Subject or legal representative must understand the investigational nature of this
             study and sign an Institutional Review Board approved written informed consent form
             prior to receiving any study related procedure

        Exclusion Criteria:

          -  Radiotherapy within the last 2 months in the area to be treated

          -  Patients with known brain metastases should be excluded from this clinical trial

          -  Tumor invading a major blood vessel (such as the carotid artery)

          -  Tumor is not clearly shown on a computed tomography (CT) scan

          -  Location and extension of the tumor precludes an effective I-PDT

          -  Patients with porphyria, or with known hypersensitivity to porphyrins or
             porphyrin-like compounds

          -  While blood cell (WBC) < 2.0 x 10^9/L

          -  Total serum bilirubin > 2.0 mg/dl

          -  Serum creatinine > 2 mg/dl

          -  Alkaline phosphatase (hepatic) > 3 times the upper normal limit

          -  Serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper limit of normal

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, acute exacerbation of congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Pregnant or nursing female subjects

          -  Unwilling or unable to follow protocol requirements and the light exposure precautions

          -  Any condition which in the Investigators' opinion deems the subject an unsuitable
             candidate to receive study drug and therapy