Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Interleukin-12

Adjuvants, Immunologic

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Participants will receive intra-tumoral injection of pIL-12 followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid DNA into tumor cells. For each lesion selected for therapy, a total of three electroporation treatments will be performed.

Plasmid IL-12 will be administered as an intratympanic (IT) injection.

IL-12p DNA

The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.

Intratumoral Electroporation

Adil Daud, MD

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.

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

Cytokine expression measured by enzyme-linked immunosorbent assay (ELISA).

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.

Number of participants with tumor response.

National Gene Vector Laboratory

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma	NCT00323206	Malignant Melan...	IL-12p DNA Intratumoral El...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma	NCT00323206	Malignant Melan...	IL-12p DNA Intratumoral El...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for intratumoral electroporation