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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
National Gene Vector Laboratory |
| Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00323206 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma |
Genetic: IL-12pDNA Procedure: electroporation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma |
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2004 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00323206 History of Changes |
| Other Study ID Numbers: | MCC-13224 |
| Study First Received: | May 5, 2006 |
| Last Updated: | January 27, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
melanoma electroporation IL-12 |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |