Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/21/2018
Start Date:June 2015
End Date:February 2022

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A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients

This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic
acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor
receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine
may target immunogenic proteins expressed in breast cancer stem cells which are the component
of breast cancer that is resistant to chemotherapy and has the ability to spread. Vaccines
made from DNA may help the body build an effective immune response to kill tumor cells.

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

Inclusion Criteria:

- Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage
therapy and now have:

- No evidence of disease (NED), or

- Stable bone only disease

- Patients who have completed standard of care and recovered with mild to no residual
toxicity from recent therapy

- Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal
antibody therapy (excluding bone-directed therapy), prior to enrollment

- Patients must be at least 28 days post systemic steroids prior to enrollment

- Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score
of =< 1

- Patients must have recovered from major infections and/or surgical procedures, and in
the opinion of the investigator, not have any significant active concurrent medical
illnesses precluding protocol treatment

- Estimated life expectancy of more than 6 months

- White blood cells (WBC) >= 3000/mm^3

- Lymphocyte count >= 800/mm^3

- Platelet count >= 75000/mm^3

- Hemoglobin (Hgb) >= 10 g/dl

- Serum creatinine =< 1.2 mg/dl when adjusted for body surface area (BSA) or creatinine
clearance > 60 ml/min

- Total bilirubin =< 1.5 mg/dl

- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 2
times upper limit of normal (ULN)

- Blood glucose < 1.5 ULN

- All patients who are having sex that can lead to pregnancy must agree to contraception
for the duration of study

Exclusion Criteria:

- Patients with any of the following cardiac conditions:

- Symptomatic restrictive cardiomyopathy

- Unstable angina within 4 months prior to enrollment

- New York Heart Association functional class III-IV heart failure on active
treatment

- Symptomatic pericardial effusion

- Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease,
prolonged daily non-steroidal anti-inflammatory use)

- Patients with any seizure disorder

- Patients with any contraindication to receiving rhuGM-CSF based products

- Patients with any clinically significant autoimmune disease uncontrolled with
treatment

- Patients who are simultaneously enrolled in any other treatment study

- Patients who are pregnant or breastfeeding
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Mary L. Disis
Phone: 206-616-1823
?
mi
from
Seattle, WA
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