Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer
|HER2/Neu Negative Recurrent Breast Carcinoma Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage III Breast Cancer||Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine Other: Laboratory Biomarker Analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients|
- Immunologic efficacy defined as achievement of a statistically significant increase in Th1 cell immunity for at least 50% of the immunizing antigens as compared to baseline [ Time Frame: Up to 5 years ]
- Incidence of toxicity per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 month after last vaccine ]The type and grade of toxicities noted during the immunization regimen will be summarized. Adverse events noted by the investigator/designated clinical research staff will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical and/or laboratory parameters.
- Memory Th1 dominant immune response to all five antigens over time [ Time Frame: Up to 12 months ]
- Modulation of MDSC with vaccination [ Time Frame: Up to 12 months ]MDSC defined as present or absent, and the probability will be estimated as a simple proportion.
- Modulation of T-regulatory (Treg) cells with vaccination [ Time Frame: Up to 12 months ]Treg defined as present or absent, and the probability will be estimated as a simple proportion.
|Actual Study Start Date:||June 2015|
|Estimated Study Completion Date:||February 2022|
|Estimated Primary Completion Date:||February 2022 (Final data collection date for primary outcome measure)|
Experimental: Treatment (STEMVAC)
Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF ID every 28 days for 3 months and booster vaccines at 6 and 12 months in the absence of disease progression or unacceptable toxicity.
Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
Other Names:Other: Laboratory Biomarker Analysis
I. To determine the safety of intradermal administration of up to 3 escalating doses of STEMVAC (CD105/Yb-1/SOX2 CDH3/MDM2-polyepitope plasmid DNA vaccine) in patients with HER2-negative advanced stage breast cancer.
II. To determine the most immunogenic dose of STEMVAC in patients with HER2-negative advanced stage breast cancer.
I. To determine whether a STEMVAC T helper 1 cells (Th1) polyepitope plasmid based vaccine elicits a persistent memory T cell response and whether immunity can be further enhanced/maintained by two additional STEMVAC vaccines (boosters) given 3 and 9 months after the priming regimen.
II. To evaluate whether STEMVAC vaccination modulates T regulatory cells and myeloid-derived suppressor cells (MDSC).
OUTLINE: This is a dose-escalation study.
Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM-CSF) intradermally (ID) every 28 days for 3 months and booster vaccines at 6 and 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up twice yearly for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02157051
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Mary L. Disis 206-616-1823 firstname.lastname@example.org|
|Principal Investigator: Mary L. Disis|
|Principal Investigator:||Mary Disis||Fred Hutch/University of Washington Cancer Consortium|