A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer

Summary

Background:

* PSA (prostate specific antigen) is a protein found on normal and cancerous prostate cells. Levels of this protein are used to identify men who are at risk for prostate cancer and to monitor responses to treatment in men who have been diagnosed with prostate cancer.
* Research has shown that men who continue to have an elevated PSA level following primary treatment for prostate cancer are at increased risk for cancer progression. Studies have shown that the change in PSA levels over time, or PSA doubling time (PSADT), can be accurate in predicting how quickly the cancer is likely to progress. Individuals with a PSADT of less than 3 months are at extremely high risk for disease progression and death from prostate cancer. Individuals with a PSADT of greater than 15 months have a very low risk of death from prostate cancer.
* T-cell receptor alternate reading frame protein (TARP) is a protein that is found in about 95% of prostate cancers and is known to stimulate the immune system. The TARP prostate cancer vaccine is made from pieces of the TARP protein called peptides and includes peptides that have been modified to make them more effective at stimulating immunity. Although these TARP peptides have been shown to stimulate the immune systems of mice, information is needed to determine if they also stimulate the immune system in humans. Since it is unclear what is the best way to give peptide vaccines, the TARP peptides will be given with substances known to stimulate the immune system or in a vaccine made with the patient s own cells.

Objectives:

* To determine the immune systems response to vaccination with TARP peptides.
* To determine the safety and toxicity of TARP peptide vaccination.
* To determine if vaccination with the TARP prostate cancer vaccine can slow down PSADT in men with an intermediate PSADT of 3 to 15 months.

Eligibility:

* Males 18 years of age and older who have completed their primary treatment for prostate cancer, have stage D0 disease, are Human leukocyte antigen (HLA) A\*0201 positive and who have a PSADT greater than 3 and less than 15 months.

Design:

* Patients will be randomized to one of two treatment arms:
* Arm A will receive the TARP vaccine with other substances that stimulate the immune system.
* Arm B will receive the TARP vaccine that includes a patients own white blood cells.
* First week of study, after screening for eligibility has been completed:
* Day 1: Apheresis procedure to extract white blood cells to test the immune response to the vaccine.
* Day 3: Flu vaccine to allow researchers to determine how well a patients immune system is working.
* Clinic visits in Weeks 3, 6, 9, 12, and 15 for physical examination, blood samples, and administration of the TARP peptide vaccine.
* Physical examination and blood samples only in Weeks 18 and 36.
* Additional blood samples and apheresis procedures in Weeks 24 and 48.
* A 6th dose of TARP peptide vaccine will be administer to those patients who have a response to vaccination at week 24.
* No follow-up or long-term study is associated with this study.

Conditions

• Prostate Specific Antigens
• Prostate Neoplasms

Interventions

BIOLOGICAL

T-cell receptor alternate reading frame protein (TARP) peptide vaccine

Will receive an admixture of the wildtype and epitope enhanced TARP peptides emulsified with Montanide ISA 51 VG and granulocyte-macrophage colony-stimulating factor (GM-CSF). TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96

BIOLOGICAL

T-cell receptor alternate reading frame protein (TARP) dendritic cell vaccine

Will receive peptide pulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.

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

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-05-11

Primary Completion

2015-02-04

Completion

2015-02-04

FDA Drug

Yes

Countries

• United States

Study Locations