Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198276
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2005-09-12
Brief Title:
Study Using the MedPulser Electroporation System With Bleomycin to Treat Cutaneous and Subcutaneous Cancer
Sponsor:
Inovio Pharmaceuticals
Organization:
Inovio Pharmaceuticals
Study Overview
Official Title:
An Open-Label Study Using the MedPulser Electroporation System to Treat Cutaneous and Subcutaneous Foci of Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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 andor permanent disfigurement requiring reconstructive surgery ie 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 ie 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
1 have failed standard treatments or who
2 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 andor appearance relative to 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 ie 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
1 have failed standard treatments or who
2 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 andor appearance relative to surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None