Brief Summary

Background: \- Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in several other types of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates, and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune system to recognize HER2. The vaccine, called adenoviral transduced autologous human epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an individual's own immune cells. These cells will be collected and used to produce the vaccine. Objectives: \- To test the safety and effectiveness of AdHER2 vaccination. Eligibility: \- Individuals at least 18 years of age who have HER2-expressing tumors. Design:

Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed.
Participants will have an apheresis procedure to collect immune cells to create the vaccine.
Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24.
Participants will be monitored with physical exams, frequent blood tests and imaging studies.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Mar 2013

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.8 years study duration

First Submitted

Initial submission to the registry

November 17, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

March 4, 2013

Completed

6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

September 10, 2022

Completed

Last Updated

September 10, 2022

Status Verified

August 1, 2022

Enrollment Period

6.8 years

First QC Date

November 17, 2012

Results QC Date

August 12, 2022

Last Update Submit

August 12, 2022

Conditions

Breast Neoplasms Breast Cancer Adenocarcinomas Metastatic Solid Tumors Characterized by HER2/Neu Expression

Keywords

Metastatic Solid TumorsHuman Epidermal Growth Factor Receptor 2 Expression (HER2/neu)Trastuzumab ExposureDendritic Cell VaccineBreast Cancer

Outcome Measures

Primary Outcomes (2)

Number of Participants With Cardiac Toxicity
Cardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is \>-53%. Below 53% is a cardiac dysfunction.
Baseline through receipt of last dose of vaccine, up to 24 weeks
Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers
Vaccine immunogenicity was determined by the number of participants who develop at least a 4-fold increase in antibody dilution titers over baseline at the time points measured. The antibody response following the vaccination was assessed using peptide-array and reported as fold increase compared to the baseline values using the cut-off of 4 fold per study definition of the vaccine immunogenicity and also of 2.5 fold to aid the interpretation of the result.
Baseline through last dose of vaccine, up to 24 weeks

Secondary Outcomes (1)

Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
At 8, 16, 24, 36, 48, 76, 100, and 124 weeks after initial vaccination

Other Outcomes (1)

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.

Study Arms (5)

1/Part I dose escalation

EXPERIMENTAL

Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at escalating doses