Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02157051|
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||February 2022|
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: Laboratory Biomarker Analysis
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157051
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Mary L. Disis 206-616-1823 email@example.com|
|Principal Investigator: Mary L. Disis|
|Principal Investigator:||Mary Disis||Fred Hutch/University of Washington Cancer Consortium|