Clinical Trial: Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: mRNA Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients

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 objective immunological and clinical responses have been observed. Most of the successful results have been observed in patients with minimal residual disease, rather than patients with advanced metastatic disease. Moreover, the investigators' preliminary results show that presence of tumor epitope specific T cells in biopsies taken from delayed type hypersensitivity (DTH) reaction sites highly correlates with prolonged progression free survival (PFS).

    Within uveal melanoma patients, a group with high risk of metastatic disease can be identified on basis of tumor specific genetic changes in loss of chromosome 3.

    At present no standard adjuvant or systemic treatment is available. Applying DC-based immunotherapy in this group of high risk patients might reduce the risk of recurrence without interference in the current treatment guidelines.

  2. Objectives

    In this joint clinical study of Radboud University Nijmegen Medical Centre (RUNMC) and Rotterdam Eye Hospital, the investigators aim to determine the in vivo immunological response induced in high risk uveal melanoma patients vaccinated with mRNA-transfected DC.

  3. Study design

    This study is an open label non-randomized phase II intervention study.

  4. Same as current

    Current Secondary Outcome: clinical response (progression free survival) [ Time Frame: 5 years ]

    Original Secondary Outcome: Same as current

    Information By: Radboud University

    Dates:
    Date Received: June 25, 2009
    Date Started: June 2009
    Date Completion:
    Last Updated: December 7, 2016
    Last Verified: September 2015