The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation System with bleomycin in the treatment of head and neck cancer.
Electroporation therapy is a tumor-specific ablative treatment modality with the potential to manage local tumors without the potentially undesirable side effects of systemic chemotherapy agents or radiotherapy. Surgical resection of solid tumors often leaves subjects with significant organ dysfunction and/or permanent disfigurement requiring reconstructive surgery. In contrast, electroporation therapy may offer equivalent disease control to conventional surgery with lessened need for reconstructive surgery. Electroporation therapy may also provide economic benefits over conventional surgical and or radiation procedures through reduced operating theatre costs, hospital stays and post treatment interventions. The ability to shrink or eliminate local tumors with the MedPulser® System when used in conjunction with intralesional Bleomycin is an important new possible treatment for the conservative local management of SCCHN and provides a possible alternative treatment option to surgical excision in the management of cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
The MedPulser device will be used in conjunction with injection of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.
Inovio Biomedical Corporation
San Diego, California, United States
To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment
Time frame: 8 Months
To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/bleomycin
Time frame: 24 Months
To evaluate organ function and appearance using the Performance Status Scale (PSS) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC QLQ - H&N 35) at 4 and 8 months following treatment
Time frame: 4 and 8 Months
To document the performance of the MedPulser® System during EPT/bleomycin treatment
Time frame: 8 Nonths
To monitor local and systemic adverse events through the Month 4 follow-up study visit
Time frame: 4 Months
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