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