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Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
PRIMARY OBJECTIVES: 1\. To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine. SECONDARY OBJECTIVES: 1. To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab. 2. To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab. 1. To determine the incidence of the development of T cell immunity specific for the HER2 ICD. 2. To determine the incidence of the development of intramolecular epitope spreading. 3. To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization. 3. To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading). OUTLINE: Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally (ID) once monthly for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and then annually thereafter for up to 5 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
March 1, 2004
Primary Completion Date
June 1, 2015
Last Updated
February 12, 2020
38
ACTUAL participants
HER-2/neu intracellular domain protein
BIOLOGICAL
leukapheresis
PROCEDURE
laboratory biomarker analysis
OTHER
sargramostim
BIOLOGICAL
immunologic technique
OTHER
synthetic tumor-associated peptide vaccine therapy
BIOLOGICAL
Lead Sponsor
University of Washington
Collaborators
NCT04585750
NCT04886531
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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