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Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139

NCT02362464 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-12-10

Study results available
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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.

Conditions

  • Prostatic Neoplasms
  • Neoplasms of Prostate
  • Prostate Cancer
  • Cancer Of Prostate
  • Stage D0 Prostate Cancer

Interventions

BIOLOGICAL

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Hoyoung M Maeng, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-12
Primary Completion
2022-03-25
Completion
2022-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02362464 on ClinicalTrials.gov