Histologically confirmed recurrent SCC, recurrent BCC, Melanoma, Adenocarcinoma (i.e., local recurrence of breast cancer), Merkel Cell Carcinoma, Cutaneous Lymphoma, other subcutaneous solid tumors (if the subcutaneous tumor is a symptomatic recurrence), or primary cutaneous tumors (if the therapeutic alternative includes disfiguring surgery).
Conditions
Interventions
Trade Name: Bleo-Kyowa
Product Name: Bleomycin Sulphate
Product Code: EPT/Bleomycin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bleomycin Sulphate
Current Sponsor code:
Sponsors
Genetronics Biomedical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with tumors suspected of involving a 50% or greater encasement of a blood vessel as measured by MRI or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize local tumor control through 6 months post-EPT/Bleomycin treatment.;Secondary Objective: - To measure pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) in subjects treated by EPT/Bleomycin. - To document the performance of the MedPulser® System during EPT/Bleomycin treatment. - To monitor local and system adverse events for 30 days post-EPT/Bleomycin treatment or until the lesion heals.;Primary end point(s): Local tumor control. 2. Secondary Endpoints • Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use). • MedPulser® Instrument and Applicator performance. • Adverse Events. | — |
Countries
United Kingdom
Outcome results
None listed