Clinical Trial Detail

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Clinical Trial Detail

Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (WOKVAC)

Complete title: A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients with Breast Cancer

Research Study Number 9626
 
Principal Investigator Nora Disis, MD
 
Phase I

Research Study Description

This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.

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

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as

-- * 0-1+ HER2 expression by immunohistochemistry (IHC) OR

-- * Fluorescence in situ hybridization (FISH) negative OR

-- * HER2 2+ and FISH negative

- Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy and may continue throughout duration of study

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

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2

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

- Hemoglobin (Hgb) >= 10 g/dl

- Lymphocyte count >= 800/mm^3

- Platelet count >= 75,000/mm^3

- Serum creatinine =< 2.0 mg/dl 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)

- Glycosylated hemoglobin measurement (HbA1c) < 5.7%

- 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

- Patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) for the duration of study participation; should a woman become pregnant while participating in the study, she should inform her study doctor immediately and will not receive any more study treatment

- Left ventricular ejection fraction (LVEF) results must be >= lower limit of normal (LLN) for institution performing based on results from the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done at baseline

- Ability to understand and the willingness to sign a written informed consent document

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

-- * Dilated 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 may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to WOKVAC

- Patients with any contraindication or known hypersensitivity to receiving sargramostatin (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products

- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this vaccine

- History of diabetes

- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C

- History of autoimmunity that has not been controlled with treatment in the last 12 months

Other exclusion criteria may apply.

Research Study Number 9626
 
Contact Nora Disis, MD
 
Telephone 206-616-1823
 
E-mail
 

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

Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

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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