Vaccine Therapy and Basiliximab in Treating Patients With Stage IV Breast Cancer

Inclusion Criteria

• Stage IV (American Joint Committee on Cancer [AJCC]) breast cancer patients who have failed at least one conventional therapy for metastatic disease
• Human leukocyte antigen (HLA)-A2 positive
• Evidence of measurable or evaluable disease by clinical, radiographic, or laboratory assessment
• Baseline Eastern Cooperative Oncology Group (ECOG) clinical performance status 0 or 1
• Life expectancy > 6 months
• White blood cells (WBC) >= 3.0
• Platelets (Plt) >= 75,000
• Hemoglobin (Hgb) >= 10 g/dl
• Serum creatinine < 1.5 times upper limit of normal
• Total bilirubin < 1.5 times upper limit of normal
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times upper limit of normal
• Contrast computed tomography (CT) and/or magnetic resonance imaging (MRI) of the brain negative for central nervous system metastases within 30 days of treatment
• Women of child bearing potential must have a negative pregnancy test (blood or urine) within 14 days before treatment and agree to use appropriate contraception from study screen through the duration of the trial; men must agree to use appropriate contraception from study screen through the duration of the trial
• Signed and dated written informed consent

Exclusion Criteria

• History of brain metastases within the last four years
• Positivity for human immunodeficiency virus (HIV)-1/HIV-2, hepatitis B virus, and hepatitis C virus active infection
• The use of the following within 14 days before treatment: * Chemotherapy * Radiation therapy * Immunosuppressive drugs * Systemic glucocorticoids * Hematopoietic growth factors * Experimental therapy
• Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment; patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study
• Initiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before treatment; patients who have been on trastuzumab for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on trastuzumab for the duration of the study
• History of bone marrow or stem cell transplantation (allogeneic or autologous)
• Pregnant women or nursing mothers
• History of alcohol abuse or illicit drug use within 12 months of study initiation
• Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
• Significant psychiatric disorder and any other reason in the Investigator’s opinion that would jeopardize protocol compliance or compromise the patient’s ability to give informed consent