Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087373
Status:
TERMINATED
Last Update Posted:
2014-06-09
First Post:
2004-07-08
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells
Status:
TERMINATED
Status Verified Date:
2012-12
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:
Vaccines may make the body build an immune response to kill tumor cells Injecting a vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of intratumoral fowlpox-TRICOM in patients with metastatic melanoma
II Determine the local response rate in patients treated with this agent III Determine systemic clinical response in patients treated with this agent
SECONDARY OBJECTIVES
I Determine the increase in transgene expression of B7-1 leukocyte function-associated antigen-3 LFA-3 and intercellular adhesion molecule-1 ICAM-1 in patients treated with this agent
II Determine the effects of this agent on CD8-positive antitumor T-cell frequency as measured by tetramer and ELISpot in patients who are HLA-A2 positive
III Correlate transgene expression of B7-1 LFA-3 and ICAM-1 by tumor cells with changes in function or number of melanoma antigen-specific CD8-positive T lymphocytes in patients treated with this agent
OUTLINE This is a multicenter study
Patients receive fowlpox-TRICOM intratumorally on day 1 of weeks 1 4 and 7 maximum of 3 injections for a single lesion course 1 After 3 injections course 1 patients with stable or responding disease receive additional injections into new lesions following the same schedule as above Treatment repeats every 9 weeks for a maximum total of 9 injections 3 injections total into a maximum of 3 different tumors total of 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then approximately every 6 months for 5-15 years
PROJECTED ACCRUAL A total of 14-28 patients will be accrued for this study within 14-28 months
I Determine the safety and tolerability of intratumoral fowlpox-TRICOM in patients with metastatic melanoma
II Determine the local response rate in patients treated with this agent III Determine systemic clinical response in patients treated with this agent
SECONDARY OBJECTIVES
I Determine the increase in transgene expression of B7-1 leukocyte function-associated antigen-3 LFA-3 and intercellular adhesion molecule-1 ICAM-1 in patients treated with this agent
II Determine the effects of this agent on CD8-positive antitumor T-cell frequency as measured by tetramer and ELISpot in patients who are HLA-A2 positive
III Correlate transgene expression of B7-1 LFA-3 and ICAM-1 by tumor cells with changes in function or number of melanoma antigen-specific CD8-positive T lymphocytes in patients treated with this agent
OUTLINE This is a multicenter study
Patients receive fowlpox-TRICOM intratumorally on day 1 of weeks 1 4 and 7 maximum of 3 injections for a single lesion course 1 After 3 injections course 1 patients with stable or responding disease receive additional injections into new lesions following the same schedule as above Treatment repeats every 9 weeks for a maximum total of 9 injections 3 injections total into a maximum of 3 different tumors total of 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then approximately every 6 months for 5-15 years
PROJECTED ACCRUAL A total of 14-28 patients will be accrued for this study within 14-28 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2012-02615 | REGISTRY | None | None |
| CDR0000374979 | None | None | None |
| UCCRC-12759A | None | None | None |
| NCI-6038 | None | None | None |
| 12759A | OTHER | None | None |
| 6038 | OTHER | None | None |