Status:
COMPLETED
Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Melanoma Stage III or IV
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as such they are able to direct the immune system specifically against cancer cells. Currently DCs are used in c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00243529
Start Date
April 1 2004
Last Update
September 29 2009
Active Locations (1)
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1
Radboud University Nijmegen Medical Center
Nijmegen, PO Box 9101, Netherlands, 6500 HB