Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer

PRIMARY OBJECTIVES:

I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP)
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE
version 4.0).

SECONDARY OBJECTIVES:

I. Quantify the relationship between the measured intra-tumor light dose and the
pathological tumor response.

TERTIARY OBJECTIVES:

I. Simulate light dose distribution within the treated tumor. II. Immune markers.

OUTLINE:

Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo
interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical
resection.

After completion of study treatment, patients are followed for 3 years.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the
oropharynx or oral cavity that are amenable to surgery

- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy
(PDT) (accessibility as determined by the physician)

- Life expectancy of at least 6 months in the judgment of the physician

- Blood urea nitrogen (BUN) =< upper limit of normal (ULN)

- White blood count > 3,000 per microliter or

- Absolute neutrophil count (ANC) > 1500 per microliter

- Serum calcium within normal limits; note: serum calcium will be corrected for low
albumin, if necessary

- 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 the duration of study participation; 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:

- Subjects who have had radiotherapy within the last 3 months

- Subjects with known brain metastases should be excluded from this clinical trial

- Tumor invading a major blood vessel (such as the carotid artery)

- Tumor invading the skull base

- Subjects with ophthalmic disease

- Tumor is not clearly shown on an imaging scan/location and extension of tumor that
precludes effective PDT, in the judgment of the primary investigator (PI)

- Location and extension of the tumor precludes an effective interstitial photodynamic
therapy (iPDT)

- Patients with known hypersensitivity to porphyrins or with porphyria

- Has distant metastasis that decreases life expectancy to less than 6 months

- 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 and the light exposure
precautions

- Any condition which in the investigator's opinion deems the subject an unsuitable
candidate to receive study drug