mRNA Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients
Phase 1/Phase 2
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Uveal Melanoma
Both
Uveal Melanoma
Trial Information
mRNA Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
immunological response
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Cornelis JA Punt, prof.MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University Nijmegen Medical Centre, Dept of Medical Oncology
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
NL22553.000.08
NCT ID:
NCT00929019
Start Date:
June 2009
Completion Date:
June 2014
Related Keywords:
- Uveal Melanoma
- uveal melanoma
- chromosome 3
- high risk
- immunotherapy
- adjuvant
- high risk genetic profile
- loss of chromosome 3
- Melanoma
- Uveal Neoplasms
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