Clinical Trial: Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Roswell Park Cancer Institute
Current Primary Outcome: Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 12 months ]
Original Primary Outcome: Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 4 months ]
Current Secondary Outcome: Serum alkaline DNase (SADA) activity [ Time Frame: Up to 12 months ]
Original Secondary Outcome:
Information By: Roswell Park Cancer Institute
Dates:
Date Received: February 18, 2014
Date Started: April 1, 2014
Date Completion:
Last Updated: May 17, 2017
Last Verified: May 2017