Melanoma (Skin) Clinical Trial
Official title:
Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients
RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor
cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma
vaccine in treating patients with stage III melanoma after surgery to remove the lymph
nodes.
OBJECTIVES:
- Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic
cells pulsed with tumor antigen peptides in patients with stage III melanoma following
lymphadenectomy.
- Determine the immune response (skin test of delayed-type hypersensitivity and flow
cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this
regimen in these patients.
- Determine clinical outcome (disease-free survival, overall survival, and adverse
events) in patients treated with this regimen.
OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells
(PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from
PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and
autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with
melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if
available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients
with no evidence of disease may receive another booster injection 5 years after the start of
vaccination.
Blood samples are examined via flow cytometry and skin testing is performed to evaluate
immune response.
;
Masking: Open Label, Primary Purpose: Treatment
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