Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab
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|ClinicalTrials.gov Identifier: NCT00194714|
Recruitment Status : Enrolling by invitation
First Posted : September 19, 2005
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|HER2/Neu Positive HLA-A2 Positive Cells Present Stage IV Breast Cancer Stage IV Ovarian Cancer||Biological: HER-2/neu Peptide Vaccine Other: Laboratory Biomarker Analysis||Phase 1 Phase 2|
I. To evaluate the safety of administering a HER2 cytotoxic T-cell (CTL) peptide-based vaccine (HER-2/neu peptide vaccine) to stage IV breast and ovarian cancer patients receiving maintenance trastuzumab.
II. To quantify and characterize antigen specific T cell subsets specific to HER2 in peripheral blood mononuclear cell (PBMC) of patients after vaccination with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.
I. To evaluate overall survival (OS) in patients who complete a vaccination series with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.
Patients receive HER-2/neu peptide vaccine intradermally (ID) once per month for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then yearly for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Combination Immunotherapy for the Generation of HER-2/Neu (HER2) Specific Cytotoxic T Cells (CTL) in Vivo|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||November 2018|
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.
Biological: HER-2/neu Peptide Vaccine
Other: Laboratory Biomarker Analysis
- Immune response measured by cytokine flow cytometry (CFC) and HLA-A2 major histocompatibility complex tetramer analysis [ Time Frame: Up to 1.5 years (12 months following the last vaccination) ]Defined as either the development of, in patients with no measurable precursors at baseline, precursor frequencies > 1:20,000 as measured by CFC; or as a 2-fold increase in baseline precursor frequency in those patients who have a pre existent immune response.
- Incidence of adverse events graded using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 [ Time Frame: Up to 7 months (30 days following the last vaccination) ]Descriptive statistics will be used to summarize changes from baseline.
- Overall survival [ Time Frame: Up to 5 years ]Survival for the Stage IV breast cancer patients will be compared to historical control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194714
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Mary Disis||Fred Hutch/University of Washington Cancer Consortium|