Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071942
Status:
TERMINATED
Last Update Posted:
2013-12-11
First Post:
2003-11-04
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of An Admixture of Recombinant Vaccinia Virus That Express DF3MUC1 and rV-TRICOM B7ICAM-1 and LFA-3 in Patients With Metastatic Adenocarcinoma of The Breast
Status:
TERMINATED
Status Verified Date:
2013-12
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 This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess the toxicity associated with repeated vaccination with an admixture of recombinant vaccinia viruses rV-MUC-1 and rV-TRICOM
II To determine the maximum tolerated dose MTD of rV-MUC-1 and rV-TRICOM vaccine admixture
III To evaluate the toxicity of adding GM-CSF to the admixture of the rV-MUC-1 and rV-TRICOM
SECONDARY OBJECTIVES
I To assess host immune reactivity following rV-MUC-1 and rV-TRICOM with and without GM-CSF administration
II To determine whether vaccination with rV-MUC-1 and rV-TRICOM with and without GM-CSF is associated with antitumor activity
OUTLINE This is an open-label dose-escalation study
Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 for a total of 2 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients including 5 HLA-A2-positive patients receive vaccination as above at the MTD and sargramostim GM-CSF subcutaneously on days 1-4 and 29-32
Patients are followed at 4 weeks monthly until disease progression and then annually for up to 15 years
PROJECTED ACCRUAL A total of 11-22 patients will be accrued for this study within 18-24 months
I To assess the toxicity associated with repeated vaccination with an admixture of recombinant vaccinia viruses rV-MUC-1 and rV-TRICOM
II To determine the maximum tolerated dose MTD of rV-MUC-1 and rV-TRICOM vaccine admixture
III To evaluate the toxicity of adding GM-CSF to the admixture of the rV-MUC-1 and rV-TRICOM
SECONDARY OBJECTIVES
I To assess host immune reactivity following rV-MUC-1 and rV-TRICOM with and without GM-CSF administration
II To determine whether vaccination with rV-MUC-1 and rV-TRICOM with and without GM-CSF is associated with antitumor activity
OUTLINE This is an open-label dose-escalation study
Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 for a total of 2 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 10 patients including 5 HLA-A2-positive patients receive vaccination as above at the MTD and sargramostim GM-CSF subcutaneously on days 1-4 and 29-32
Patients are followed at 4 weeks monthly until disease progression and then annually for up to 15 years
PROJECTED ACCRUAL A total of 11-22 patients will be accrued for this study within 18-24 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 |
|---|---|---|---|
| NCI-2012-03131 | REGISTRY | None | None |
| DFCI-02310 | None | None | None |
| NCI-5747 | None | None | None |
| 02-310 | OTHER | None | None |
| 5747 | OTHER | None | None |
| U01CA062490 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062490 |