Status:
COMPLETED
Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer
Lead Sponsor:
Inovio Pharmaceuticals
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00198276
Start Date
February 1 2004
End Date
September 1 2008
Last Update
October 3 2017
Active Locations (1)
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1
Inovio Biomedical Corporation
San Diego, California, United States, 92121