Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005943
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-07-05
Brief Title:
Gene Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Phase I Study Using Direct Combination DNA Injections for the Immunotherapy of Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2001-10
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-2 into a persons melanoma cells may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of liposome complexed staphylococcal enterotoxin B and interleukin-2 plasmid DNA in patients with metastatic melanoma II Determine local gene expression in tumor tissues in this patient population treated with this regimen III Determine if plasmid DNA can be detected in circulation following intratumoral injection of this regimen in this patient population IV Evaluate the antitumor immune responses induced by this treatment regimen in these patients V Characterize the clinical response to this treatment regimen in terms of tumor size and histology in these patients VI Determine the clinical response to this treatment regimen in terms of complete remission partial remission stable disease and disease progression in these patients
OUTLINE This is a dose escalation study Patients receive intratumoral liposome complexed staphylococcal enterotoxin B SEB and interleukin-2 IL-2 plasmid DNA injections into 1-3 tumor nodules once every 2 weeks Treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity Patients with complete regression during therapy may receive additional therapy to previously untreated tumor nodules Patients with partial response at 4 weeks following the last injection may continue therapy once every 4 weeks until no residual tumor remains Cohorts of 3 patients each receive escalating doses of SEB and IL-2 plasmid DNA until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities Patients are followed until death
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive intratumoral liposome complexed staphylococcal enterotoxin B SEB and interleukin-2 IL-2 plasmid DNA injections into 1-3 tumor nodules once every 2 weeks Treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity Patients with complete regression during therapy may receive additional therapy to previously untreated tumor nodules Patients with partial response at 4 weeks following the last injection may continue therapy once every 4 weeks until no residual tumor remains Cohorts of 3 patients each receive escalating doses of SEB and IL-2 plasmid DNA until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities Patients are followed until death
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None