NCT00198263

Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer

An Open-Label Study Using the Medpulser® Electroporation System to Treat Head and Neck Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation System with bleomycin in the treatment of head and neck cancer.

Detailed description

Electroporation therapy 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 solid tumors often leaves subjects with significant organ dysfunction and/or permanent disfigurement requiring reconstructive surgery. In contrast, electroporation therapy may offer equivalent disease control to conventional surgery with lessened need for reconstructive surgery. Electroporation therapy may also provide economic benefits over conventional surgical and or radiation procedures through reduced operating theatre costs, hospital stays and post treatment interventions. The ability to shrink or eliminate local tumors with the MedPulser® System when used in conjunction with intralesional Bleomycin is an important new possible treatment for the conservative local management of SCCHN and provides a possible alternative treatment option to surgical excision in the management of cancer.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Medpulser Electroporation with Bleomycin	The MedPulser device will be used in conjunction with injection of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area.

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-09-20
• Last updated: 2017-10-03

Locations

1 site across 1 country: United States