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NCT02362451 · ClinicalTrials.gov registry record · Phase 2
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT02362451: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02362451 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02362451, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the change in PSA levels over time. This is called the PSA doubling time (PSADT). Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the PSA has become detectable again or has started to rise after primary treatment, but has not spread to other organs. Objectives: \- To test a vaccines effectiveness on the rate of PSA increase using PSADT and tumor growth rates. Eligibility: \- Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months. Design: * Participants will be screened with blood tests, scans, physical exam, and medical history. Their prostate cancer will be confirmed. * Participants will undergo apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm. * Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects. * Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12, 15, and 24. Both will be made from the participants own cells. * Participants will be selected randomly to receive either active vaccine or placebo. For every two participants assigned to active vaccine, one participant will be assigned to placebo vaccine. * Participants will get a Vaccine Report Card to to complete after receiving vaccine. * The study lasts 96 weeks.
Interventions
- BIOLOGICAL Autologus elutriated monocyte placebo vaccine
- BIOLOGICAL Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-07-10 |
| Est. Completion | 2020-02-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02362451
The ClinicalTrials.gov registry entry for NCT02362451 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 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 2 interventions - of which Autologus elutriated monocyte placebo vaccine is the first listed.
NCT02362451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02362451 about?
NCT02362451 is a clinical study titled "Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer". Background: \- Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the...
What is the current status of trial NCT02362451?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2015-07-10. Estimated completion is 2020-02-13.
What interventions are being tested in trial NCT02362451?
The interventions under investigation include: Autologus elutriated monocyte placebo vaccine (BIOLOGICAL), Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02362451?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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