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Clinical Trial Detail

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

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

Research Study Number 9140
Principal Investigator Nora Disis, MD
Phase I

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.

Research Study Number 9140
Contact Jennifer Childs
Telephone (206) 616-2305

Keywords: Breast Cancer; Solid Tumors; Neoplasms; HER2-Negative; Immunotherapy

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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