Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00323206|
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Biological: IL-12p DNA Procedure: Intratumoral Electroporation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Experimental: Intra-tumoral Electroporation of pIL-12
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.
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.
Other Name: plasmid electroporation
- Maximum Tolerated Dose (MTD) [ Time Frame: 8 weeks ]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.
- Local and Systemic Response [ Time Frame: 8 weeks ]Number of participants with tumor response.
- Local and Systemic Expression of IL-12 and IFN Gamma [ Time Frame: 8 weeks ]Cytokine expression measured by enzyme-linked immunosorbent assay (ELISA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323206
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Adil Daud, MD||H. Lee Moffitt Cancer Center and Research Institute|