The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.
Recurrent tumors in head and neck squamous cell carcinoma usually have a poor prognosis. In patients suitable for salvage surgery of their recurrent disease, the success rate for local control has been reported to be 40-50%. The surgical treatment of H\&N SCC frequently results in significant loss of organ function (e.g., inability to swallow, speak, etc.) and/or permanent disfigurement. There is a compelling and unmet medical need for a local therapy that destroys tumors while preserving function status and appearance in patients with primary, recurrent, or metastatic H\&N SCC. Comparison: To compare function status at 4 months after treatment with bleomycin-EPT or surgery in patients with locally recurrent or second primary SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx or larynx that have failed primary curative therapy and in whom surgical resection is seen as an option for disease control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.
Patients have their tumor surgically removed.
Inovio Biomedical Corporation
San Diego, California, United States
Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35)
Time frame: 4 Months
Local tumor recurrence, disease free survival and overall survival rates through 2 years after bleomycin-EPT or surgery treatment
Time frame: 4 Months
Safety through 6 months after the study treatment
Time frame: 6 Months
Durability of function status outcomes at 8 months after bleomycin-EPT or surgery treatment
Time frame: 8 Months
Pharmacoeconomic parameters through 8 months after bleomycin-EPT or surgery treatment
Time frame: 8 Months
Bleomycin systemic absorption and plasma pharmacokinetics following intratumoral (IT) bleomycin-EPT administration
Time frame: 96 Hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.