DC Vaccine (TH1 Dendritic Cell Immunotherapy) for the Treatment of Cutaneous Angiosarcoma

Inclusion Criteria

• Patients with histologically confirmed cutaneous head & neck angiosarcoma deemed to be potentially resectable and who are deemed to be good candidates for postoperative therapy with radiation and study treatment
• Should be willing to undergo biopsy to provide fresh frozen tumor tissue for use in the creation of the vaccine
• 18 years of age or older and able to provide informed consent
• Hemoglobin >= 8.0 gm/dL
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Lymphocytes >= 500 cells/mm^3
• Platelet count >= 75,000 /mm^3
• CD4+ T-cell counts >= 200/mm^3
• Glomerular filtration rate (GFR) > 60 mL/min/m^2
• Total bilirubin =< 1.5 times upper limit of normal (ULN)
• Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times the ULN
• Thyroid-stimulating hormone (TSH) range between 0.4 – 4.0 mIU / L
• Activated partial thromboplastin time (aPTT) or international normalized ratio (INR) =< 1.5 x ULN unless subject is receiving anticoagulant therapy. If receiving anticoagulant therapy, patient is eligible as long as prothrombin time, international normalized ratio (INR), or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Exclusion Criteria

• Locally advanced tumors deemed unresectable and/or metastatic tumors
• Received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine
• Uncontrolled human immunodeficiency virus (HIV) infection with CD4+ < 200 cells/ul or active hepatitis B virus (HBV) or hepatitis C virus (HCV) disease that requires antiviral therapy
• Need for concurrent therapy with corticosteroids or any systemic immunosuppressive agents during the vaccination phase of the study
• History of systemic autoimmune disease
• Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study treatment. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first treatment
• Concurrent participation on another therapeutic clinical trial
• Patients unwilling or unable to comply with the protocol or provide informed consent