Vaccine Therapy in Treating Patients With Metastatic Melanoma

OBJECTIVES:

- To assess the toxicity and immune responses in patients with HLA-A*0201-positive,
chemotherapy-resistant, metastatic melanoma treated with escalating doses of autologous
dendritic cell-adenovirus CCL21 vaccine.

- To assess clinical responses in these patients.

OUTLINE: Patients receive intradermal injections of autologous dendritic cell-adenovirus
CCL21 vaccine once on days 1, 8, 22, and 36. Patients achieving stable disease or response
to therapy may receive a second course at least 1 and no more than 6 months from the last
vaccine administration.

Blood samples are collected at baseline and after treatment for immunologic studies. Samples
are analyzed for MART-1 and gp100-specific CD8+ T-cells and KLH-specific CD4+ T helper cells
by ELISPOT assay; cytotoxic T-cells by chromium release assays; and CD8+ T-cells by
tetramer-specific flow cytometry and FACS analysis. Patients also undergo tissue biopsies
after treatment. Tissue samples are analyzed for numbers of CD3, CD8, CD4 T-cells, CD56 NK,
and CD19 B-cells, and levels of local CCL21 by IHC.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.