Inclusion Criteria:

1. Males or females of all races ≥ 18 and ≤ 75 years of age;
2. Unresectable Stage III or IV melanoma (at least 0.5 cm in diameter), arising from primary cutaneous, mucosal, or subungal melanoma of any tumor thickness, with any number of lymph nodes involved, or in-transit metastases, or distant metastases;
3. ECOG performance status of 0 or 1;
4. Subjects who have had previous brain metastases must have been treated without progression and asymptomatic for more than 1 month;
5. One or more cutaneous, subcutaneous, or lymphatic melanoma metastases accessible for injection of dendritic cells and for subsequent biopsy evaluation;
6. Adequate baseline hematological and organ function assessed by laboratory values within 30 days prior to study entry as follows: granulocytes > 2500/mm3, lymphocytes > 1000/ mm3, platelets > 100,000/ mm3, serum creatinine < 1.5 x ULN, AST, ALT, GGT, LDH, alkaline phosphatase < 2.5 x ULN, serum bilirubin < 1.5 x ULN, absolute neutrophils > 500/ mm3;
7. An expected survival of at least 24 weeks;
8. Females must be post-menopausal or surgically sterile or practice effective contraception; Men who are not surgically sterile and whose partners are not post-menopausal or surgically sterile must practice effective contraception;
9. Normal coagulation parameters as measured by PT/PTT;
10. Signed, IRB-approved voluntary informed consent.

Exclusion Criteria:

1. Active, acute viral, bacterial, or fungal infections requiring specific therapy;
2. HIV-infection due to concerns about ability to mount an effective immune response;
3. Active autoimmune disease requiring steroids or other immunosuppressive therapy;
4. Untreated brain metastases diagnosed by contrast-enhanced CT/PET/MRI scans;
5. Recipients of organ allografts;
6. Other concurrent malignant disease excluding other cancers of the skin;
7. Less than 30 days (from the first dose of study medication) have elapsed since the completion of prior chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any first line therapy;
8. Allergic skin diseases, including eczema, psoriasis, and neurodermatitis;
9. History of or concurrent severe cardiac insufficiency (New York Heart Association Class III or IV) or coronary artery disease;
10. Acute medical conditions such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk;
11. Concurrent severe anemia (hemoglobin < 8g/L) that cannot be supported by transfusion;
12. History of or current bleeding or clotting disorders;
13. Concurrent immunosuppressive therapy such as corticosteroids and cyclosporin A;
14. Concurrent investigational treatments, or treatment with an investigational treatment within the past 30 days (from the first dose of study medication);
15. Concurrent medications that are metabolized by the CYP450 3A4 pathway (Section 14.9);
16. Females who are lactating or pregnant;
17. Any medical or psychiatric condition which, in the opinion of the investigator, would unacceptably reduce the safety or delivery of the proposed treatment, or would preclude obtaining voluntary informed consent.