Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Gene Vector Laboratory | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-tumoral Electroporation of pIL-12 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-12p DNA | Biological | Plasmid IL-12 will be administered as an intratympanic (IT) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Local and Systemic Response | Number of participants with tumor response. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Local and Systemic Expression of IL-12 and IFN Gamma | Cytokine expression measured by enzyme-linked immunosorbent assay (ELISA). | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adil Daud, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
Not provided
| Label | URL |
|---|---|
| H Lee Moffiitt Cancer Center \& Research Institute website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D010957 | Plasmids |
| ID | Term |
|---|---|
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intratumoral Electroporation | Procedure | The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated. |
|
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |