Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer|
- Local tumor control [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- MedPulser instrument and applicator performance [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2004|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Bleomycin 4.0 U/mL at dose of 1 U/cm^3 of treatment area; Medpulser EP
Device: MedPulser Electroporation with bleomycin
The MedPulser device will be used in combination with Bleomycin Sulfate injection around the tumor area in a concentration of 1 U/ml per cm3 of tumor treatment area.
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:
- have failed standard treatments; or who
- 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.
|United States, California|
|Inovio Biomedical Corporation|
|San Diego, California, United States, 92121|
|Study Chair:||Paul Goldfarb, MD||Inovio Pharmaceuticals|