Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

Exclusion Criteria

• •High dose curative radiotherapy within 30 days in the area to be treated. Tumor invading a major blood vessel.
• •Tumor is not measurable on a computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• •Location and extension of the tumor precludes a potentially effective I-PDT.
• •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• •Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds.
• •Platelet count \< 75,000.
• •Total serum bilirubin \> 2 mg/dL
• •Alkaline phosphatase (hepatic) \> 3 times the upper normal limit
• •Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 3 times the upper normal limit
• •Patients with moderately to severely impaired creatinine clearance (crcl \< 44) will be excluded.
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic 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.
• •Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive porfimer sodium