Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients
Melanoma Stage III or IV

About this trial
This is an interventional treatment trial for Melanoma Stage III or IV focused on measuring Dendritic cells, Melanoma, Vaccine, Immunotherapy, RNA, Peptides
Eligibility Criteria
Inclusion Criteria: For both stage III and IV Histological proof of cutaneous melanoma Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining, HLA type A2 and/or A3, with known HLA-DR4 expression, WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l. Expected adequacy of follow-up, Written informed consent. For Stage III only Stage III melanoma according to the 2001 AJCC criteria. Start of treatment within 2 months of lymph node dissection for melanoma stage III For stage IV only -Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal Exclusion Criteria: For both stage III and IV No autoimmune disorders, no concomitant use of immunosuppressive drugs, no serious concomitant disease, no serious active infections, no other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin, No known allergy to shell fish (contains KLH) are excluded. No pregnancy or lactation, For stage III only: No signs or symptoms of distant metastases as defined by normal history, physical examination, chest X-ray and serum LDH. No concomitant or previous systemic treatment for melanoma For stage IV only: No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this. No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.
Sites / Locations
- Radboud University Nijmegen Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
MHC Class I restricted epitopes
MHC Class I and II restricted epitopes
mRNA transfected DC
HLA-A2.1 patients are vaccinated with dendritic cells loaded with MHC Class I restricted epitopes of tumor antigens gp100 and tyrosinase
HLA-A2.1 and HLA-DR4 patients are vaccinated with dendritic cells loaded with MHC Class I and II restricted epitopes of tumor antigens gp100 and tyrosinase
HLA-A2.1 and/or HLA-DR4 patients are vaccinated with dendritic cells transfected with mRNA encoding tumor antigens gp100 and tyrosinase