Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028652
Status:
TERMINATED
Last Update Posted:
2019-12-13
First Post:
2002-01-04
Brief Title:
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Treament of Spontaneous Tumor Metastases With IL-12 DNA NSC 709933 A Phase IB Trial
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Inserting the gene for interleukin-12 into a persons 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0025 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-CO-9771 | None | None | None |
| WCCC-HSC-1998-257 | None | None | None |