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 ]

A logistic model will be fit to the relationship between the probability of changes in tumor response with intra-tumoral light dose. Wald tests of the model effects will be performed to assess statistical significance at the 0.1 level of significance. A number of diagnostic plots and statistics will be calculated in the evaluation of the model fit.


Original Primary Outcome: Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 4 months ]

A logistic model will be fit to the relationship between the probability of changes in tumor response with intra-tumoral light dose. Wald tests of the model effects will be performed to assess statistical significance at the 0.1 level of significance. A number of diagnostic plots and statistics will be calculated in the evaluation of the model fit.


Current Secondary Outcome: Serum alkaline DNase (SADA) activity [ Time Frame: Up to 12 months ]

SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.


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