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Evaluating the T Cell Response to a Peptide-based Vaccine in Patients With Breast Cancer

NCT00892567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-12-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate T cell responses against a peptide-based vaccine in patients with breast cancer and to determine whether peptide-specific T cells can be found at the site of breast tumors following vaccination.

Conditions

  • Breast Neoplasms

Interventions

BIOLOGICAL

9 Peptides from Her-2/neu, CEA, & CTA

Each vaccination will be administered on days 1, 8, 15, 36, 43, and 50. All participants will receive 9 class I MHC-restricted synthetic peptides and a class II MHC-restricted tetanus helper peptide administered in Montanide ISA-51. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Craig L Slingluff, Jr

    lead OTHER

Principal Investigators

  • David R. Brenin, M.D. · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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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 NCT00892567 on ClinicalTrials.gov