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NCT01730118 · ClinicalTrials.gov registry record · Phase 1
Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01730118: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01730118 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01730118, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BIOLOGICAL Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-03-04 |
| Est. Completion | 2019-12-03 |
| Phase | Phase 1 |
What the finished NCT01730118 record still lists
NCT01730118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine is the first listed.
NCT01730118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01730118 about?
NCT01730118 is a clinical study titled "Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing". 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 asso...
What is the current status of trial NCT01730118?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-03-04. Estimated completion is 2019-12-03.
What interventions are being tested in trial NCT01730118?
The interventions under investigation include: Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01730118?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01730118's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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