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Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer

NCT02362451 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-03-18

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Autologus elutriated monocyte placebo vaccine

20x10\^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24

BIOLOGICAL

Multi-epitope (ME) T-cell receptor g alternate reading frame protein (TARP) vaccine

20x10\^6 viable cells/dose 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
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-10
Primary Completion
2020-02-13
Completion
2020-02-13
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 NCT02362451 on ClinicalTrials.gov