Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1
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|ClinicalTrials.gov Identifier: NCT03630809|
Recruitment Status : Suspended (Suspended for protocol revisions)
First Posted : August 15, 2018
Last Update Posted : October 19, 2021
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 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with HER-2/neu-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 participant's immune system to fight infection. This study vaccine will be made from the participant's blood cells collected from a procedure called leukapheresis.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer HER2-positive Breast Cancer HER-2 Gene Amplification HER2 Positive Breast Carcinoma HER-2 Protein Overexpression Breast Cancer, Male Breast Cancer Female||Biological: HER2 DC1 Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine|
|Actual Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: HER2 DC1 Vaccine
HER2 DC1 vaccine given in 3 booster injections administered every 3 months for the treatment of participants with nonmetastatic HER2pos breast cancer (BC) with low HER2 immunity and history of prior treatment with HER2 DC1 vaccines.
Biological: HER2 DC1 Vaccine
Ultrasound (US) guided intranodal delivered vaccines will be administered at each participating site by a radiologist experienced in ultrasound guided procedures along with the principal investigator or his/her designee. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1 right and 1 left normal groin lymph nodes.
Other Name: Vaccine
- Rate of HER2 Immune Activation [ Time Frame: Up to 5 years ]HER2 immune activation will be assessed by cluster of differentiation 4 (CD4)+ T-Helper Cell Type 1 (Th1) response assay, as examined in unexpanded peripheral blood mononuclear cells pulsed ex vivo with 6 Major Histocompatibility Complex (MHC) II HER2 peptides. Activation will be measured in peripheral blood by the summation of spots (i.e., ELISPOT for IFN-γ, IL-4, and IL-10) for 6 distinct peptides and reported as total SFC/10^6 cells.
- Rate of Restored anti-HER2 CD4 Th1 at 5 Years [ Time Frame: Up to 5 years ]Assessment of the baseline anti-HER2 CD4 low response percentage after prior vaccination with HER2-DC1 vaccine. Anti-HER2 CD4 Th1 will be measured by simple ELISPOT using peripheral blood at study entry and every 12 months for a total of 5 years. High anti-HER2 CD4 immunity is defined by ELISPOT as low response to individual HER2 peptide > 50 Spot-Forming Cells (SFCs)/2 x 10^5 peripheral blood mononuclear cells.
- Rate of Treatment Emergent Adverse Events [ Time Frame: Up to 5 years ]Serious adverse events will be recorded for 100 days after study treatment. Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630809
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Ricardo Costa, M.D.||H. Lee Moffitt Cancer Center and Research Institute|