Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT02068157|
Recruitment Status : Terminated (Study no longer has an active IDE)
First Posted : February 21, 2014
Results First Posted : August 28, 2017
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interstitial Photodynamic Therapy During Standard Chemotherapy for Palliation of Patients With Head and Neck Squamous Cell Carcinoma - Phase II|
|Actual Study Start Date :||April 1, 2014|
|Actual Primary Completion Date :||October 13, 2016|
|Actual Study Completion Date :||November 4, 2016|
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
- Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1 [ Time Frame: Up to 12 months ]Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068157
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Hassan Arshad||Roswell Park Cancer Institute|