Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
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.
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Drug: porfimer sodium
Drug: photodynamic therapy
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||May 2017 (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.
Drug: porfimer sodium
Other Names:Drug: photodynamic therapy
Undergo image-guided I-PDT
Other Names:Other: laboratory biomarker analysis
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||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Hassan Arshad|
|Principal Investigator:||Hassan Arshad||Roswell Park Cancer Institute|