Clinical trial · Interventional
Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer
An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer
NCT00198276CI-TRIAL-00029753completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MedPulser Electroporation with bleomycin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bleomycin
- description
- Bleomycin 4.0 U/mL at dose of 1 U/cm\^3 of treatment area; Medpulser EP
- interventionNames
- Combination Product: MedPulser Electroporation with bleomycin
Primary outcomes (1)
- measure
- Local tumor control
- timeFrame
- 6 Months
Secondary outcomes (3)
- measure
- Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use)
- timeFrame
- 24 Months
- measure
- MedPulser instrument and applicator performance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 units. 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 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. 8. Life expectancy of at least 6 months. 9. 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) scan. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.