Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
Condition: Stage I Oral Cavity Squamous Cell Carcinoma; Stage II Oral Cavity Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: HPPH; Laboratory Biomarker Analysis; Photodynamic Therapy; Quality-of-Life Assessment; Therapeutic Conventional Surgery
Intervention description: Given IV; Correlative studies; Undergo PDT; Ancillary studies; Undergo standard of care surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works
      compared to standard of care surgery in treating patients with oral cavity cancer.
      Photodynamic therapy can destroy or control disease by using a combination of drug, such as
      HPPH, and light and may be as effective as surgery in treating patients with oral cavity
      cancer.
    

Eligibility criteria:

        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