Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

• •1. The presence of SCC of the base of the tongue, posterior lateral pharyngeal wall, hypopharynx, or larynx must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment.
• •2. Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control.
• •3. The length of the longest diameter of the study lesion must be \< 5 cm and the calculated treatment volume must be \< 60.0 cm3 (tumor volume plus a 0.5 cm margin around the tumor) for the study lesion \[where treatment volume = 0.5 (A+1) (B+1)2 and where A = length of the longest diameter (cm), B = the next longest diameter perpendicular to "A" (cm)\].
• •4. Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
• •5. Age: 18 years or older.
• •6. Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT.
• •7. Hematopoietic status:
• •* Absolute neutrophil count (ANC) \> 1000/uL
• •* Platelets \> 75,000/mm3
• •* Prothrombin time: international normalized ratio (PT: INR) 1.5 (correctable with vitamin K injection)
• •8. Blood chemistry status:
• •* Transaminases \< 3 times upper limit of normal
• •* Total bilirubin \< 2.5 mg/dL
• •* Creatinine \< 2.5mg/dL
• •9. A written Informed Consent form must be signed prior to the patient receiving any study procedures or treatments.