Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03630809
Status:
TERMINATED
Last Update Posted:
2022-04-25
First Post:
2018-08-10
Brief Title:
Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Quality of the data originating from prior versions of the protocol has been affected by protocol deviations triggered by the COVID-19 pandemics
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2neu HER-2neu positive breast cancer in the past who were previously treated with HER-2neu-directed dendritic cells DC vaccines
There is evidence that the use of anti-HER2 dendritic cell DC study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence
This study will use a Dendritic Cell Type 1 DC1 vaccine which is a HER2-sensitized dendritic cell DC study vaccine Dendritic cells are immune cells that can tell the participants immune system to fight infection This study vaccine will be made from the participants blood cells collected from a procedure called leukapheresis
There is evidence that the use of anti-HER2 dendritic cell DC study vaccines could improve response to breast cancer therapy and be an important step in the prevention of recurrence
This study will use a Dendritic Cell Type 1 DC1 vaccine which is a HER2-sensitized dendritic cell DC study vaccine Dendritic cells are immune cells that can tell the participants immune system to fight infection This study vaccine will be made from the participants blood cells collected from a procedure called leukapheresis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None