NCT00323206

Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to study a type of gene therapy treatment called plasmid electroporation. This type of treatment involves the injection of a gene into some melanoma tumors located near the surface of the skin, followed by a burst of electricity into the tumor to cause the tumor to take up the gene. This study is a Phase I study to determine the side effects and the correct dose of this type of treatment and also its effectiveness in treating melanoma. While the electroporation technique has been used in people, the combination of plasmid injection and electroporation is being tried in human beings for the first time.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	IL-12p DNA	Plasmid IL-12 will be administered as an intratympanic (IT) injection.
PROCEDURE	Intratumoral Electroporation	The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-05-09
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States