Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082641
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2004-05-14
Brief Title:
NeoadjuvantAdjuvant Chemotherapy Vaccine Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
1 Adenovirus p53 Infected DC Vaccine For Breast Cancer 2 Translation of Biotechnology Into the Clinic
Status:
COMPLETED
Status Verified Date:
2023-09
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 may make the body build an immune response to kill tumor cells Drugs used in chemotherapy such as doxorubicin cyclophosphamide and paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving vaccine therapy before andor after chemotherapy and radiation therapy may cause a stronger immune response
PURPOSE This randomized phase III trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53
PURPOSE This randomized phase III trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of two different schedules of vaccination comprising p53-infected autologous dendritic cells in women with p53-overexpressing stage III breast cancer undergoing neoadjuvant or adjuvant chemotherapy and adjuvant radiotherapy
Determine the immune response in terms of humoral and cellular response in patients treated with these regimens
Determine antigen-specific immune responses in patients treated with these regimens
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 2 treatment arms
All patients undergo apheresis for the collection of peripheral blood monocytes that are cultured with interleukin-4 and sargramostim GM-CSF to produce dendritic cells The dendritic cells are infected with a recombinant adenoviral vector containing the wild-type p53 gene
Patients receive doxorubicin IV and cyclophosphamide IV every 2 weeks for 8 weeks 4 courses followed 2 weeks later by paclitaxel IV every 2 weeks for 8 weeks 4 courses Patients with stage III disease then undergo surgery Three weeks after completion of paclitaxel or after surgery for patients with stage III disease patients undergo radiotherapy once daily for 65 weeks Patients are then receive vaccine therapy as per the arm to which they were randomized
Arm I Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously SC 1 week after completion of doxorubicin and cyclophosphamide 1 week after completion of paclitaxel or after surgery for patients with stage III disease and at 6 and 12 weeks after completion of radiotherapy for a total of 4 vaccinations
Arm II Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6 8 10 and 12 weeks after completion of radiotherapy
Treatment in both arms continues in the absence of unacceptable toxicity
Patients are followed at 1 month every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-50 patients 10-25 per treatment arm will be accrued for this study within 2 years
Determine the safety and toxicity of two different schedules of vaccination comprising p53-infected autologous dendritic cells in women with p53-overexpressing stage III breast cancer undergoing neoadjuvant or adjuvant chemotherapy and adjuvant radiotherapy
Determine the immune response in terms of humoral and cellular response in patients treated with these regimens
Determine antigen-specific immune responses in patients treated with these regimens
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 2 treatment arms
All patients undergo apheresis for the collection of peripheral blood monocytes that are cultured with interleukin-4 and sargramostim GM-CSF to produce dendritic cells The dendritic cells are infected with a recombinant adenoviral vector containing the wild-type p53 gene
Patients receive doxorubicin IV and cyclophosphamide IV every 2 weeks for 8 weeks 4 courses followed 2 weeks later by paclitaxel IV every 2 weeks for 8 weeks 4 courses Patients with stage III disease then undergo surgery Three weeks after completion of paclitaxel or after surgery for patients with stage III disease patients undergo radiotherapy once daily for 65 weeks Patients are then receive vaccine therapy as per the arm to which they were randomized
Arm I Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously SC 1 week after completion of doxorubicin and cyclophosphamide 1 week after completion of paclitaxel or after surgery for patients with stage III disease and at 6 and 12 weeks after completion of radiotherapy for a total of 4 vaccinations
Arm II Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6 8 10 and 12 weeks after completion of radiotherapy
Treatment in both arms continues in the absence of unacceptable toxicity
Patients are followed at 1 month every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-50 patients 10-25 per treatment arm 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 |
|---|---|---|---|
| 3P30CA036727-20S1 | NIH | CTRP Clinical Trials Reporting System | httpsreporternihgovquickSearch3P30CA036727-20S1 |
| CDR0000354507 | REGISTRY | None | None |
| NCI-2012-01019 | REGISTRY | None | None |