This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Undergo interstitial photodynamic therapy using temoporfin
Undergo surgical resection
Correlative studies
Undergo interstitial photodynamic therapy using temoporfin
Frequency of adverse events, graded according to NCI CTCAE version 4.0
The frequency of toxicities will be tabulated by grade.
Time frame: Up to 30 days after surgical resection
Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
Time frame: Day 3
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm\^2), microscopic area using a 40x objective.
Time frame: Up to 6 weeks
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