CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02362464
NCT02362464Phase 2Completed

A Pilot Study of Long Term TARP Vaccination Using A Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccine in Previously Vaccinated Men on NCI 09-C-0139.

National Cancer Institute (NCI)·interventional·Posted Feb 13, 2015·Updated Dec 10, 2024

In Brief

A Phase 2 clinical trial evaluating Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine for Prostatic Neoplasms and 4 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

Background: \- Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to give those same men the new version of the vaccine. They want to see if it produces different types of immune responses and also ensure that repeated vaccinations are safe. Objectives: \- To find out the long-term safety of repeated T-cell receptor alternate reading frame protein (TARP) peptide vaccinations. Eligibility: \- Men who took part in National Cancer Institute (NCI) protocol 09-C-0139. Design: * Participants will be screened with blood tests, scans, physical exam, medical history, and an evaluation of how well they perform everyday activities. * Participants will have 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 vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine will be made from the participants own cells. * Participants will get a Vaccine Report Card to complete after receiving vaccine. * The study lasts 96 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 13, 2015
Enrollment StartMay 12, 2015
Primary CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 11.4 years ago

Interventions

Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccinebiological

dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.