Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer

Completed · Phase 4

Conditions studied: Cancer

In brief

The purpose of the study is to study the safety and efficacy of MedPulser Electroporation with bleomycin treatment of cutaneous and subcutaneous foci of cancer.

Key facts

Study ID

NCT00198276

Run by

Inovio Pharmaceuticals

People needed

88

Starts

2004-02-01

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 recurrent SCC, recurrent BCC, melanoma, adenocarcinoma (i.e., local recurrence of breast cancer), merkel cell carcinoma, cutaneous lymphoma, other subcutaneous solid tumors, or primary cutaneous tumors must be confirmed by histological examination of a tissue (e.g., biopsy) sample obtained within 1 month prior to a patient signing the informed consent form for the study.
• Total volume of disease treated will require a dose of bleomycin sulfate less than 80 units.
• Tumors and margins must be completely accessible to intralesional bleomycin injections and the EPT applicator electrodes.
• Age: 18 years or older.
• Male or female.
• Men and women of childbearing potential must be using physician 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 a 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.
• 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 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.