Clinical Trials Directory

Trials / Terminated

TerminatedNCT03630809

Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1

Immune Response Surveillance and Potential Booster Vaccines for Patients Who Have Received HER2-pulsed DC1 Vaccine

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
16 (actual)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALHER2 DC1 VaccineUltrasound (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.

Timeline

Start date
2019-01-10
Primary completion
2022-04-11
Completion
2022-04-11
First posted
2018-08-15
Last updated
2022-04-25

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03630809. Inclusion in this directory is not an endorsement.