Type I-Polarized Autologous Dendritic Cell Vaccine With Tumor Blood Vessel Antigen-Derived Peptides in Metastatic Breast Cancer Patients

Inclusion Criteria:

Patients must be human leukocyte antigen (HLA)-A2+
Histologically confirmed breast cancer
Patients must have evidence of metastatic disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease; Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable 10 mm soft tissue component that meets the measurability criteria per RECIST
There is no limit to the number of prior systemic treatment regimens
Patients must have a life expectancy of > 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Prior GEM therapy is acceptable as long as the last dose was ≥ 3 months from registration on this study
Patients may have treated and stable brain metastases; they must be off steroids and must have had stable brain metastases for at least 6 months
White blood cell (WBC) > 3.0 x 10^9/L
Platelets > 100 x 10^9/L
Hemoglobin (Hgb) ≥ 10.0 gm/dl
Creatinine < 1.5 mg/dl
Bilirubin (total) < 2.0 ml/dl
Aspartate aminotransferase (AST) < 5.0 x normal institutional limits
Alkaline phosphatase < 2.5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases)
Serum calcium ≤ 12 mg/dl
International normalized ratio (INR) < 1.5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study
All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
Patients must have a negative pregnancy test by urinalysis
Use of an effective means of contraception (men and women) is mandated in subjects of child-bearing potential; female subjects will be advised that they not become pregnant for at least one month after completing participation in the study; avoiding sexual activity is the only certain method to prevent pregnancy; however, if subjects choose to be sexually active, they should use an appropriate "double barrier" method of birth control (such as female use of a diaphragm, intrauterine device [IUD], or contraceptive sponge, in addition to male use of a condom) or the use of prescribed "birth control" pills, injections, or implants

Exclusion Criteria:

HLA-A2 negative patients
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
Presence of bleeding diathesis
Current treatment on another clinical trial
Patients with organ allografts
Pregnancy or breast-feeding; female patients must be surgically sterile or be post-menopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment; male patients must be surgically sterile or must agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study