Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer
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|ClinicalTrials.gov Identifier: NCT00198276|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Combination Product: MedPulser Electroporation with bleomycin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||MedPulser Electroporation with Belomycin|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Bleomycin 4.0 U/mL at dose of 1 U/cm^3 of treatment area; Medpulser EP
Combination Product: 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.
- Local tumor control [ Time Frame: 6 Months ]
- Pharmacoeconomic factors (e.g. hospital costs, extent of medical interventions, medication use) [ Time Frame: 24 Months ]
- MedPulser instrument and applicator performance [ Time Frame: 6 Months ]
- Adverse events [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198276
|United States, California|
|Inovio Biomedical Corporation|
|San Diego, California, United States, 92121|
|Study Chair:||Paul Goldfarb, MD||Inovio Pharmaceuticals|