Our study population consists of HLA-A2.1 positive patients with a high risk uveal melanoma (stage II) with proven expression of melanoma associated antigens tyrosinase and/or gp100. Patients are identified as high risk due to their genetic profile, i.e. loss of chromosome 3. Patients are included within 12 months after local treatment.
Conditions
Interventions
Product Name: mRNA-electroporated Dendritic cell product
Pharmaceutical Form: Solution for injection
Sponsors
Radboud University Nijmegen Medical Centre
Rotterdam Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - histologically documented evidence of uveal melanoma - HLA-A2.1 phenotype is required - melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory) - high risk genetic profile (loss of chromosome 3) as determined by FISH - interval since local treatment of uveal melanoma is 3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, serum crea-tinine 3 months - age 18-75 years - expected adequacy of follow-up - no pregnant or lactating women - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - history of second malignancy, adequately treated basal cell carcinoma or carcinoma in situ of the cervix is acceptable - serious active infections, HbsAg or HIV positive - autoimmune diseases or organ allografts - concomitant use of immunosuppressive drugs - known allergy to shell fish (since it contains KLH)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first objective is to study the efficacy of autologous mRNA-transfected monocyte-derived DC in terms of progression free survival (PFS) in high-risk uveal melanoma patients.;Secondary Objective: The secondary objectives are: • to study the toxicity of mRNA-transfected DC injected i.d./i.v and • to study the in vivo immunological response to this treatment Toxicity will be assessed using the Clinical Toxicity Criteria NCI CTC version 3.0. The in vivo immunological response will be assessed as: - proliferative and humoral response to KLH - cytokine production of KLH stimulated PBMC - tumor antigen-specific T cell responses in peripheral blood - tumor antigen-specific T cell responses in biopsies from DTH - cytokine production of T cells in biopsies from DTH - cytotoxicity of T cells in biopsies from DTH - immunohistochemical characterization of DTH infiltrating lymphocytes ;Primary end point(s): The primary endpoint is progression-free survival determined as no signs of disease. | — |
Countries
Netherlands
Outcome results
None listed