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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity

Conditions
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Stage I Oral Cavity Squamous Cell Carcinoma, Stage II Oral Cavity Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: HPPH
* Other: Laboratory Biomarker Analysis
* Drug: Photodynamic Therapy
* Other: Quality-of-Life Assessment
* Procedure: Therapeutic Conventional Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (surgery)<br>Patients undergo standard of care surgery on day 1. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Procedure: Therapeutic Conventional Surgery<br>* Undergo standard of care surgery<br>|
| Experimental: Arm II (HPPH, PDT)<br>Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1. | Drug: HPPH<br>* Given IV<br>* Other names: Photochlor;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Photodynamic Therapy<br>* Undergo PDT<br>* Other names: Photoradiation Therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1 | Objective tumor response will be tabulated overall. | At 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4 | In the analysis of QoL simple data analyses will initially take place including individual participant-level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time points and between group comparisons | Baseline up to 24 months | 
| Adverse Events as Graded by CTCAE Version 4.0 Are Reported | The frequency of toxicities will be tabulated by grade. | Up to 30 days after administration of HPPH |