Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227474
Status:
WITHDRAWN
Last Update Posted:
2013-01-24
First Post:
2005-09-26
Brief Title:
S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0348 A Phase II Study of 5T4-Modified Vaccinia Ankara MVA Vaccine TROVAX in Patients With Advanced Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
SWOG has decided to not pursue this trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission
Detailed Description:
OBJECTIVES
Determine the feasibility of conducting a live viral vaccine trial using adjuvant recombinant modified vaccinia Ankara-5T4 vaccine TroVax in patients with stage IIIB-IV breast cancer in remission
Determine the progression-free survival of patients treated with this vaccine
Determine the 5T4-specific T-cell immune response in patients treated with this vaccine
Determine the toxicity of this vaccine in these patients
Determine the level of 5T4-specific antibody response in patients treated with this vaccine
Correlate preliminarily immune response with 3- and 12-month progression-free survival of patients treated with this vaccine
Correlate tumor 5T4 expression with overall survival and progression-free survival of patients treated with this vaccine
Correlate tumor infiltrating lymphocyte and CD1a-positive dendritic cell density with development of 5T4-specific T-cell immunity in patients treated with this vaccine
OUTLINE This is a multicenter study
Patients receive recombinant modified vaccinia Ankara-5T4 vaccine TroVax intramuscularly once a month in months 1-3 Patients then receive booster vaccinations once in months 6 9 and 12 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 2 years
Determine the feasibility of conducting a live viral vaccine trial using adjuvant recombinant modified vaccinia Ankara-5T4 vaccine TroVax in patients with stage IIIB-IV breast cancer in remission
Determine the progression-free survival of patients treated with this vaccine
Determine the 5T4-specific T-cell immune response in patients treated with this vaccine
Determine the toxicity of this vaccine in these patients
Determine the level of 5T4-specific antibody response in patients treated with this vaccine
Correlate preliminarily immune response with 3- and 12-month progression-free survival of patients treated with this vaccine
Correlate tumor 5T4 expression with overall survival and progression-free survival of patients treated with this vaccine
Correlate tumor infiltrating lymphocyte and CD1a-positive dendritic cell density with development of 5T4-specific T-cell immunity in patients treated with this vaccine
OUTLINE This is a multicenter study
Patients receive recombinant modified vaccinia Ankara-5T4 vaccine TroVax intramuscularly once a month in months 1-3 Patients then receive booster vaccinations once in months 6 9 and 12 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0348 | OTHER | None | None |