Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
- Conditions
- Metastatic Cancer
- Registration Number
- NCT00028652
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.
- Detailed Description
OBJECTIVES:
* Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases.
* Determine the antitumor immune response in patients treated with this regimen.
* Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients.
* Compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks.
OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). Patients are assigned to 1 of 2 treatment arms.
* Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5.
* Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12.
Patients with stable or responding disease may receive 1 subsequent course beginning on day 29.
Patients are followed at 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 12 patients (6 per treatment group) will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center🇺🇸Madison, Wisconsin, United States