Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052351
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-01-24
Brief Title:
Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study Of Sequential Vaccinations With Recombinant Vaccinia-CEA6D-TRICOM And Recombinant Fowlpox-CEA6D-TRICOM B71ICIAM-1LFA-3 With Sargramostim GM-CSF In Conjunction With Standard Adjuvant Chemotherapy In High Risk Breast Cancer Patients Status Post Surgery With 4 Or More Lymph Nodes And CEA Expressing Tumors
Status:
COMPLETED
Status Verified Date:
2003-05
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 Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells
PURPOSE Randomized clinical trial to study the effectiveness of vaccine therapy plus sargramostim and combination chemotherapy in treating women who have undergone surgery for stage II or stage III breast cancer that has spread to the lymph nodes
PURPOSE Randomized clinical trial to study the effectiveness of vaccine therapy plus sargramostim and combination chemotherapy in treating women who have undergone surgery for stage II or stage III breast cancer that has spread to the lymph nodes
Detailed Description:
OBJECTIVES
Compare the immunological effects of 2 different schedules of vaccinia-CEA-TRICOM vaccine fowlpox-CEA-TRICOM vaccine and sargramostim GM-CSF administered with standard adjuvant chemotherapy in women with high-risk stage II or III breast cancer
Compare the safety of these regimens in these patients
Determine the feasibility of obtaining determinations of CD4 response in patients treated with these regimens
Compare disease-free survival of patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Vaccinia-CEA-TRICOM Beginning 2-3 weeks after surgery and before initiation of standard adjuvant chemotherapy all patients receive vaccinia-CEA-TRICOM vaccine subcutaneously SC on day 1 and sargramostim GM-CSF SC on days 1-4 of week 1
Fowlpox-CEA-TRICOM Patients are treated on 1 of the following schedules
Arm I During chemotherapy patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of weeks 2 5 8 11 14 17 20 and 23 After chemotherapy patients receive additional vaccinations on weeks 26 38 and 50
Arm II Prior to chemotherapy patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of week 2 After chemotherapy patients receive additional vaccinations on weeks 26 38 and 50
Chemotherapy Patients receive doxorubicin IV over 5-7 minutes and cyclophosphamide IV over 30 minutes on day 1 of weeks 3 6 9 and 12 Patients then receive paclitaxel IV over 3 hours on day 1 of weeks 15 18 21 and 24 Treatment continues in the absence of disease progression after at least 1 course of chemotherapy or unacceptable toxicity
Radiotherapy Patients undergo radiotherapy during weeks 26-32 in the absence of disease progression
Patients with hormone-receptor positive tumors receive oral tamoxifen for 5 years beginning on approximately week 32
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 28 14 per treatment arm patients will be accrued for this study within 18 months
Compare the immunological effects of 2 different schedules of vaccinia-CEA-TRICOM vaccine fowlpox-CEA-TRICOM vaccine and sargramostim GM-CSF administered with standard adjuvant chemotherapy in women with high-risk stage II or III breast cancer
Compare the safety of these regimens in these patients
Determine the feasibility of obtaining determinations of CD4 response in patients treated with these regimens
Compare disease-free survival of patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Vaccinia-CEA-TRICOM Beginning 2-3 weeks after surgery and before initiation of standard adjuvant chemotherapy all patients receive vaccinia-CEA-TRICOM vaccine subcutaneously SC on day 1 and sargramostim GM-CSF SC on days 1-4 of week 1
Fowlpox-CEA-TRICOM Patients are treated on 1 of the following schedules
Arm I During chemotherapy patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of weeks 2 5 8 11 14 17 20 and 23 After chemotherapy patients receive additional vaccinations on weeks 26 38 and 50
Arm II Prior to chemotherapy patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of week 2 After chemotherapy patients receive additional vaccinations on weeks 26 38 and 50
Chemotherapy Patients receive doxorubicin IV over 5-7 minutes and cyclophosphamide IV over 30 minutes on day 1 of weeks 3 6 9 and 12 Patients then receive paclitaxel IV over 3 hours on day 1 of weeks 15 18 21 and 24 Treatment continues in the absence of disease progression after at least 1 course of chemotherapy or unacceptable toxicity
Radiotherapy Patients undergo radiotherapy during weeks 26-32 in the absence of disease progression
Patients with hormone-receptor positive tumors receive oral tamoxifen for 5 years beginning on approximately week 32
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 28 14 per treatment arm patients will be accrued for this study within 18 months
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-5191 | None | None | None |
| NCI-03-C-0005 | None | None | None |