Interstitial Photodynamic Therapy in Treating Patients With Recurrent Oropharynx or Oral Cavity Cancer
This phase II trial studies the effects of interstitial photodynamic therapy in patients with oropharynx or oral cavity 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 oropharynx or oral cavity cancer.
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Drug: porfimer sodium
Drug: photodynamic therapy
|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.
|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. Approximately 44-52 hours after porfimer sodium administration, patients undergo image-guided I-PDT.
Drug: porfimer sodium
Other Names:Drug: photodynamic therapy
Undergo image-guided I-PDT
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. Approximately 44-52 hours after porfimer sodium administration, patients undergo image-guided I-PDT.
After completion of study treatment, 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|