A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines With Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma

Inclusion Criteria:

- Metastatic melanoma with measurable disease after attempted curative surgical therapy
and without prior chemotherapy; adjuvant interferon or isolated limb perfusion is
allowed.

- Tumor tissue must be available for immunohistochemical analysis, and specimens will
stained for MART-1/tyrosinase/NY-ESO-1 by immunohistochemical staining and will also
be stained for HMB-45 by immunohistochemistry, and positivity for at least one will
be an entry requirement.

- Patients must be HLA-A *0201 positive by a DNA polymerase chain reaction (PCR)
analysis.

- Serum creatinine of 2.0 mg/dl or less, total bilirubin of 2.0 mg/dl or less, and
alanine transaminase/aspartic transaminase (ALT/AST) of less than 3X institutional
upper limit of normal (ULN).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Patients must be able to understand and sign an Institutional Review Board (IRB)
approved informed consent form.

- Patients must have whit blood count (WBC) of 3000 or greater, platelets of 100,000 or
greater, and hemoglobin of 9.0 gm/dl or more.

- Patients must be seropositive for Epstein-Barr virus (EBV).

- Patients with unresectable stages III/IV uveal melanoma and metastatic mucosal
melanoma will be eligible for this trial.

Exclusion Criteria:

- Patients who are undergoing or have undergone in the past month any other therapy for
their melanoma, including radiation therapy, chemotherapy and adjuvant therapy.

- Have major systemic infections, coagulation disorders, or other major medical
illnesses (MI) of the cardiovascular or respiratory systems, or have had a documented
MI in the last 6 months.

- Require steroid therapy.

- Are pregnant or lactating.

- Are known to be positive for hepatitis BsAg, Hepatitis C or human immunodeficiency
virus (HIV) antibody, since cells for DC cannot be grown in the laboratory when virus
contaminated.

- Have a prior history of uveitis or autoimmune inflammatory eye disease.

- Have previously received the gp100 209-217 (210M), MART-1 26-35 (27L), gp100 280-288
(288V), tyrosinase 207-215 or NY-ESO-1 157-165 (165V) peptides.

- Have had another malignancy other than cervical carcinoma-in-situ or basal cell

/squamous cancer of the skin, unless they have undergone curative therapy more than 5
years ago and are still free of detectable disease.

- Since this trial increase the risk of immunological impairment, patients with the
following will be excluded from this trial: Hypogammaglobulinemia, Lymphocytopenia,
History of impaired immune response, tuberculosis (TB) or positive purified protein
derivative (PPD) unless they have received BCG vaccine.