Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
|Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Laryngeal Verrucous Carcinoma Recurrent Lip and Oral Cavity Squamous Cell Carcinoma Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary Recurrent Oral Cavity Verrucous Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Tongue Carcinoma||Other: Laboratory Biomarker Analysis Drug: Photodynamic Therapy Drug: Porfimer Sodium||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II|
- 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.
- 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.
|Actual Study Start Date:||April 1, 2014|
|Study Completion Date:||November 4, 2016|
|Primary Completion Date:||October 13, 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (porfimer sodium, image-guided I-PDT)
Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Photodynamic Therapy
Undergo image-guided I-PDT
Other Names:Drug: Porfimer Sodium
I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02068157
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Hassan Arshad||Roswell Park Cancer Institute|