Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Radboud University Medical Center
With
Dutch Cancer Society
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
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