Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer

PRIMARY OBJECTIVES:

I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry
system can be used to tailor this therapy to individual patients.

OUTLINE:

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then
undergo image-guided I-PDT on day 2.

After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then
every 2 months for up to 12 months.

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