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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

PSA Doubling Time (PSADT) and slope log (PSA) were calculated at every study visit using the PSADT Memorial Sloane Kettering nomogram. The values were calculated to demonstrate the rate of rise of PSA, expressed as the velocity in nanograms/mL/year, or the PSA doubling time, in months or years. PSA is a tumor marker for prostate cancer and after surgery (undetectable - e.g. \<0.2 ng/mL) or radiation PSA should fall to a very low level when the disease is effectively treated. When PSA increases (

Interventions

  • BIOLOGICAL Autologus elutriated monocyte placebo vaccine
  • BIOLOGICAL Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2015-07-10
Est. Completion 2020-02-13
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

Why NCT02362451 stopped before completion

NCT02362451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Autologus elutriated monocyte placebo vaccine is the first listed.

NCT02362451 does not publish any study locations in the registry export this page uses.

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.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT02362451's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT02362451, the US trial registry maintained by the National Library of Medicine. NCT02362451 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.