Dendritic Cell Vaccine and Gemcitabine Hydrochloride in Treating Patients with Metastatic Breast Cancer

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 (within 14 days of study entry)
• Platelets > 100 x 10^9/L (within 14 days of study entry)
• Hemoglobin (Hgb) >= 10.0 gm/dl (within 14 days of study entry)
• Creatinine < 1.5 mg/dl (within 14 days of study entry)
• Bilirubin (total) < 2.0 ml/dl (within 14 days of study entry)
• Aspartate aminotransferase (AST) < 5.0 x normal institutional limits (within 14 days of study entry)
• Alkaline phosphatase < 2.5 upper limit of normal (ULN) (< 10 x ULN in presence of bone metastases) (within 14 days of study entry)
• Serum calcium =< 12 mg/dl (within 14 days of study entry)
• International normalized ratio (INR) < 1.5, except for subjects receiving warfarin therapy (within 14 days of study entry); 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
• Women of child bearing potential 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