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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Plasmid IL-12 will be administered as an intratympanic (IT) injection.
The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Maximum Tolerated Dose (MTD)
MTD of intralesionally electroporated IL-12 plasmid (pIL-12) as well as a recommended dose for Phase II study. Dose-Limiting Toxicity (DLT): will be defined as hematologic toxicities or diarrhea greater than grade 3, and nonhematologic toxicities greater than grade 2 as defined in the NCI common toxicity criteria, Version 3.0. Significant local skin breakdown, cellulitis, bleeding or ulceration will preclude treatment of particular tumor nodules although treatment of other nodules can continue.
Time frame: 8 weeks
Local and Systemic Response
Number of participants with tumor response.
Time frame: 8 weeks
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