Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes
Recruitment status was: Recruiting
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.
Biological: HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine
Biological: HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine
Biological: autologous melanoma lysate-pulsed autologous dendritic cell vaccine
Biological: autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine
Biological: dendritic cell-idiotype-keyhole limpet hemocyanin vaccine
Other: flow cytometry
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients|
- Immune response [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||October 2002|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082198
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw|
|Warsaw, Poland, 02-781|
|Principal Investigator:||Sergiusz Markowicz, MD||Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology|