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NCT00323206 · ClinicalTrials.gov registry record · NA
Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma
A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT00323206: Completed NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00323206 is a NA study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00323206, a NA study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- BIOLOGICAL IL-12p DNA
- PROCEDURE Intratumoral Electroporation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-06 |
| Est. Completion | 2008-04 |
| Phase | NA |
What the finished NCT00323206 record still lists
NCT00323206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which IL-12p DNA is the first listed.
NCT00323206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00323206 about?
NCT00323206 is a clinical study titled "Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma". 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...
What is the current status of trial NCT00323206?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2004-06. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00323206?
The interventions under investigation include: IL-12p DNA (BIOLOGICAL), Intratumoral Electroporation (PROCEDURE).
Who is sponsoring clinical trial NCT00323206?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00323206's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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