Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Clinical Trial
Official title:
A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
This phase I trial studies the side effects and best dose of photodynamic therapy using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.
PRIMARY OBJECTIVES: I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers. SECONDARY OBJECTIVES: I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients. II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens. III. Observe for wound complications. OUTLINE: This is a dose-escalation study of laser light. Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2. After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician. ;
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