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An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer

Phase 4
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

An Open-Label Study Using the Medpulser® Electroporation System to Treat 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.

Inclusion Criteria:

1. The presence of primary oral cavity, primary pharyngeal, primary laryngeal, salivary
gland, limited recurrent and second primary tumors must be confirmed by histological
examination of a tissue sample (e.g., biopsy) obtained within 2 months of the subject
receiving the study treatment.

2. The length of the longest diameter of the study lesion must be < 5 cm and the
calculated treatment volume (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)]
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 prescribed
contraceptive 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 without

- Grade 1: Restricted in physically strenuous activity but ambulatory and able to
carry out work of a light or sedentary nature, e.g., light house work, office

- Grade 2: Ambulatory and capable of all self-care, but unable to carry out any
work 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 procedures
or treatments.

Exclusion Criteria:

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

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 greater
than 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 with
pacemaker 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize local tumor recurrence through 8 months post-EPT/bleomycin treatment

Outcome Time Frame:

8 Months

Safety Issue:


Principal Investigator

Paul Goldfarb, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Inovio Pharmaceuticals


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2004

Completion Date:

September 2008

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • cancer
  • bleomycin
  • medpulser
  • electroporation
  • primary oral cavity, primary pharyngeal, primary laryngeal, salivary gland, limited recurrent and second primary tumors
  • Head and Neck Neoplasms



Inovio Biomedical CorporationSan Diego, California  92121