In Vivo Responses of DC Vaccines Presenting HLA Class I and II Restricted Tumor Epitopes Either by Peptide-pulsing or mRNA Transfection in Melanoma Patients
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.