Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer
Information source: Inovio Biomedical Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: MedPulser Electroporation with bleomycin (Device)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Inovio Biomedical Corporation
Official(s) and/or principal investigator(s):
Paul Goldfarb, MD, Study Chair, Affiliation: Inovio Biomedical Corporation
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.
Official title: An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Local tumor control
Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use)
MedPulser instrument and applicator performance
Electroporation therapy (EPT) 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 cutaneous lesions may lead to
significant organ dysfunction and/or permanent disfigurement requiring reconstructive surgery
(i. e. nose, eye area, ears, medial canthus, nasolabial fold, lip, scalp, etc.). In contrast,
electroporation therapy may offer equivalent disease control to conventional surgery with a
lessened need for reconstructive surgery.
The ability to ablate local cutaneous lesions with the MedPulser® System when used in
conjunction with intralesional Bleomycin is an important new treatment for the local
management of recurrent Basal Cell Carcinoma (BCC), recurrent Squamous Cell Carcinoma (SCC),
Melanoma, Adenocarcinoma (i. e. local recurrence of breast cancer), Merkel Cell Carcinoma and
Cutaneous Lymphoma and other solid tumors with symptomatic subcutaneous recurrences and
provides an alternative treatment option to subjects who:
1. have failed standard treatments; or who
2. are unwilling or unsuitable to undergo conventional surgical excision or radiation.
EPT with Bleomycin spares normal tissue and its use in local disease management may preserve
organ function and/or appearance relative to surgery.
Minimum age: 18 Years.
Maximum age: N/A.
1. 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.
2. Total volume of disease treated will require a dose of bleomycin sulfate less than 80
3. Tumors and margins must be completely accessible to intralesional bleomycin injections
and the EPT applicator electrodes.
4. Age: 18 years or older.
5. Male or female.
6. Men and women of childbearing potential must be using physician prescribed
contraceptive methods while undergoing protocol related therapy.
7. Baseline performance status: ECOG 0-2
- Grade 0: Fully active, able to carry on all pre-disease performance without
- 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
- 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.
8. Life expectancy of at least 6 months.
9. Sign a written Informed Consent prior to receiving any study procedures or
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 with a significant history of emphysema or pulmonary fibrosis.
6. Subjects with indwelling cardiac pacemakers who cannot tolerate a period with
pacemaker turned off.
7. Subjects with a history of uncontrolled cardiac arrhythmia.
8. Women who are pregnant, or are nursing.
Locations and Contacts
Inovio Biomedical Corporation, San Diego, California 92121, United States
Starting date: February 2004
Ending date: September 2008
Last updated: December 4, 2007