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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03630809
Recruitment Status : Suspended (Suspended for protocol revisions)
First Posted : August 15, 2018
Last Update Posted : October 19, 2021
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with a diagnosis of nonmetastatic or metastatic breast cancer in complete clinicla response classic HER2pos (ie, IHC 3+ or FISHpos) breast cancer (BC) who have previously been vaccinated with DC1 HER2-pulsed vaccines on any of several prior clinical trials for ductal carcinoma in situ (DCIS) or inflammatory breast cancer (IBC) are eligible; however, we also allowed HER2 2+ patients in many of these prior trials and they will also be allowed to participate in this trial. Note: HER2pos BC is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification. The lack of HER2 overexpression by IHC is defined as 0 or 1+ whereas overexpression is defined as 3+. In the event of equivocal IHC, 2+, the tumor must be gene-amplified by fluorescent in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio > 2 and HER2 copy number > 4 define HER2negdisease).
  • Patients with nonmetastatic HER posBC must have completed all standard-of-care treatment for nonmetastatic BC (e.g., surgery, chemotherapy, radiation therapy, and HER2-targeted therapy). Note: antiestrogen therapy is permitted while on trial. Note: antiestrogen therapy is permitted while on trial.
  • Patients with diagnosis of metastatic HER2 pos breast cancer must have complete tumor response to current treatment per RECIST 1.1 and completed all standard-of-care chemotherapy. Note: maintenance treatment with approved HER2-targeted agents and/or antiestrogen therapy is permitted while on trial.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Participants must have normal organ and marrow function within 2 weeks of registration.
  • For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose.
  • Must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Uncontrolled congenital or acquired immune deficiency that is requiring treatment that would interfere with study treatment will not be allowed on study. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded.
  • No other prior malignancy is allowed except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Any other cancer from which the patient has been disease free for at least 3 years.
  • Pregnant or breast feeding.
  • Known to be HIV positive.
  • Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
  • Major surgery within 4 weeks of initiation of study drug.
  • Have not recovered to ≤ Grade 1 or tolerable Grade 2 adverse events (AEs) due to agents administered ≥ 28 days earlier, as documented by the treating investigator.
  • Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug. Note: patients enrolled on another HER2 vaccine trial but not receiving active therapy can enroll in this study.
  • Not able to comply with the treatment schedule and study procedures for any reason.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03630809

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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
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Principal Investigator: Ricardo Costa, M.D. H. Lee Moffitt Cancer Center and Research Institute
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT03630809    
Other Study ID Numbers: MCC-19650
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
classic HER2
Nonmetastatic classic HER2
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs