Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer

PRIMARY OBJECTIVES:

I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by
comparing the rate of tumor response after PDT to those observed after surgery, at 24 months
post treatment.

SECONDARY OBJECTIVES:

I. To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery.

II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).

TERTIARY OBJECTIVES:

I. Immune markers (T cells). II. To investigate the correlation of the diffuse reflectance
optical spectroscopy with tumor response to PDT.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard of care surgery on day 1.

ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0 and undergo PDT on day
1.

After completion of study treatment, patients are followed up every 3-4 months in year 1 and
every 3-6 months in year 2.

Inclusion Criteria:

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

- Participants with previously untreated T1/T2 N0 squamous cell carcinoma of the oral
cavity with or without extension to the oropharynx

- Histologically confirmed squamous cell carcinoma of the target tumor(s)

- Tumor thickness is 4 mm or less (measured clinically and/or by computed tomography
[CT] or magnetic resonance imaging [MRI] scan)

- CT or MRI of the neck to confirm staging

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

- Life expectancy of at least 12 months in the judgment of the physician

- Participants 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 is participating in this study, she should inform
her treating physician immediately

- Participant 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:

- Those who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6
weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have
not recovered from adverse events due to agents administered more than 4 weeks earlier

- Those 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

- Those with porphyria or with known hypersensitivity to porphyrins or porphyrin-like
compounds

- White blood cells (WBC) < 4,000

- Total serum bilirubin > 2 mg/dL

- Serum creatinine > 2 mg/dL

- Alkaline phosphatase (hepatic) or serum glutamic-oxaloacetic transaminase (SGOT) > 3
times the upper normal limit

- Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion
(LVI)

- 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

- Nodal disease as detected by clinical exam or CT

- Pregnant or nursing females

- Unwilling or unable to follow protocol requirements

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

- Received an investigational agent within 30 days prior to enrollment

- Trismus or compromised airway

- Previous treatment in the target tumor area