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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01730118
The ClinicalTrials.gov registry entry for NCT01730118 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.