Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity
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
I. Quantify the relationship between the measured intra-tumor light dose and the
pathological tumor response.
I. Simulate light dose distribution within the treated tumor. II. Immune markers. III.
Circulating endothelial cells.
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
After completion of study treatment, patients are followed up at 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of adverse events, graded according to NCI CTCAE version 4.0
The frequency of toxicities will be tabulated by grade.
Up to 30 days after surgical resection
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|