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

Completed · Phase 4

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00198263

Run by

Inovio Pharmaceuticals

People needed

95

Starts

2004-01-01

Expected to finish

2008-09-01

Last updated by the study team

2017-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Age: 18 years or older.
• Male or female.
• Men and women of childbearing potential must be using Investigator prescribed contraceptive methods while undergoing protocol related therapy.
• Baseline performance status: ECOG 0-2:
• Grade 0: Fully active, able to carry on all pre-disease performance without restriction.
• 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 work.
• 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.
• Life expectancy of at least 6 months.
• Subjects must sign a written Informed Consent prior to receiving any study procedures or treatments.

You may not qualify if…

• 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) scan.
• Subjects with tumors having bone invasion.
• Subjects with hypersensitivity to bleomycin.
• Subjects who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
• Subjects deemed unsuitable for general anesthesia.
• Subjects with a significant history of emphysema or pulmonary fibrosis.
• Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.
• Subjects with a history of uncontrolled cardiac arrhythmia.
• 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.

Where it is running

• Inovio Biomedical Corporation — San Diego, California, United States

Full record on ClinicalTrials.gov

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