Status:
TERMINATED
Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Rotterdam Eye Hospital
Conditions:
Uveal Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
1. Rationale Immunotherapy applying ex vivo generated and tumor antigen-loaded dendritic cells (DC) has now successfully been introduced in the clinic. A limited, but consistent, number of objecti...
Eligibility Criteria
Inclusion
- histological documented uveal melanoma
- HLA-A2.1 phenotype (intervention arm)
- non-HLA-A2.1 phenotype (control arm)
- melanoma expressing gp100 and/or tyrosinase
- high risk genetic profile (loss of chromosome 3) determined by FISH
- interval since local treatment of uveal melanoma \< 12 months
- no signs of liver metastasis determined by diagnostic CT-abdomen
- normal serum LDH
- no signs of cerebral metastases
- bilirubin \< 25 micromol/l
- WHO performance scale 0-1
- age 18-75 years
- written informed consent
- expected adequacy of followup
- no pregnant or lactating women
Exclusion
- history of second malignancy, except adequately treated basal cell carcinoma
- serious active infections
- autoimmune disease or organ allografts
- concomitant use of immunosuppressive drugs
- known allergy to shell-fish
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00929019
Start Date
June 1 2009
End Date
April 1 2016
Last Update
December 7 2018
Active Locations (2)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500HB
2
The Rotterdam Eye Hospital
Rotterdam, South Holland, Netherlands, 3000LM