Status:
COMPLETED
Augmentation of Dendritic Cell-Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells in Stage IV Melanoma Patients
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Dendritic cells (DC) are the professional antigen presenting cells of the immune system. Multiple distinct DC lineage's exist and it is now well appreciated that the DC subset and the maturation stage...
Eligibility Criteria
Inclusion
- Histologically documented evidence of melanoma.
- Stage IV melanoma according to the 2001 AJCC criteria. \[53\] Limited tumor burden; LDH \< 2x upper limit of normal.
- HLA-A2.1 phenotype according to lymphocyte HLA typing.
- Expression of gp100 and/or tyrosinase on melanoma cells, as detected by immunohistochemistry, preferably on metastatic tumor, but if not available on primary tumor.
- ECOG performance status 0-1, life expectancy \> 3 months.
- Age 18-75 years. -
- Written informed consent.
- Expected adequacy of follow-up.
- 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.
Exclusion
- No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases 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.
- No previous treatment with monoclonal antibodies.
- No concomitant use of corticosteroids or other immunosuppressive agents.
- No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period.
- No serious concomitant disease, no active infections. Specifically, patients with autoimmune disease or organ allografts, and HBsAg or HIV positive patients are excluded.
- Patients with a known allergy to shell fish (contains KLH) are excluded.
- Patients with asthma or severe allergic disease necessitating medication are excluded
- No pregnant or lactating women.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00847106
Start Date
March 1 2004
End Date
October 1 2005
Last Update
February 19 2009
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