Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer

Inclusion Criteria:

1. The presence of primary oral cavity, primary pharyngeal, primary laryngeal, salivarygland, limited recurrent and second primary tumors must be confirmed by histologicalexamination of a tissue sample (e.g., biopsy) obtained within 2 months of the subjectreceiving the study treatment.

2. The length of the longest diameter of the study lesion must be < 5 cm and thecalculated treatment volume (tumor volume plus a 0.5 cm margin around the tumor) forthe study lesion [where treatment volume = 0.5 (a+1) (b+1)2 and where a = length ofthe longest diameter (cm), b = the next longest diameter perpendicular to "a" (cm)]must be < 60.0 cm3.

3. Age: 18 years or older.

4. Male or female.

5. Men and women of childbearing potential must be using Investigator prescribedcontraceptive methods while undergoing protocol related therapy.

6. Baseline performance status: ECOG 0-2:

• Grade 0: Fully active, able to carry on all pre-disease performance withoutrestriction.

• Grade 1: Restricted in physically strenuous activity but ambulatory and able tocarry out work of a light or sedentary nature, e.g., light house work, officework.

• Grade 2: Ambulatory and capable of all self-care, but unable to carry out anywork activities. Up and about more than 50% of waking hours.

7. Life expectancy of at least 6 months.

8. Subjects must sign a written Informed Consent prior to receiving any study proceduresor treatments.

Exclusion Criteria:

1. Subjects with tumors suspected of involving a 50% or greater encasement of a bloodvessel as measured by magnetic resonance imaging (MRI) or computed tomography (CT)scan.

2. Subjects with tumors having bone invasion.

3. Subjects with hypersensitivity to bleomycin.

4. Subjects who have received or will exceed a total lifetime dose of bleomycin greaterthan 400 units.

5. Subjects deemed unsuitable for general anesthesia.

6. Subjects with a significant history of emphysema or pulmonary fibrosis.

7. Subjects with indwelling cardiac pacemakers who cannot tolerate a period withpacemaker turned off.

8. Subjects with a history of uncontrolled cardiac arrhythmia.

9. Women who are pregnant, or are nursing. Women must have a negative pregnancy test (urine pregnancy tests are acceptable) within 7 days of study treatment.