This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.
PRIMARY OBJECTIVES: I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients. OUTLINE: Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Roswell Park Cancer Institute
Buffalo, New York, United States
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 12 months
Serum Alkaline DNase (SADA) Activity
SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
Time frame: Up to 12 months
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