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About
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.
Full 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 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:
EPT with Bleomycin spares normal tissue and its use in local disease management may preserve organ function and/or appearance relative to surgery.
Enrollment
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Volunteers
Inclusion criteria
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
Life expectancy of at least 6 months.
Sign a written Informed Consent prior to receiving any study procedures or treatments.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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88 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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