Loading clinical trials...
Loading clinical trials...
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Warsaw, Poland
Start Date
October 1, 2002
Primary Completion Date
April 1, 2010
Last Updated
August 26, 2013
22
ESTIMATED participants
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
BIOLOGICAL
flow cytometry
OTHER
adjuvant therapy
PROCEDURE
Lead Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
NCT04079166
NCT04911998
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions