Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Immune response
No
Sergiusz Markowicz, MD
Principal Investigator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Unspecified
CDR0000666511
NCT01082198
October 2002
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