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

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Brief Title

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

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. Study population

           The investigators' study population consists of HLA-A2 positive patients with a high
           risk uveal melanoma with proven expression of melanoma associated antigens tyrosinase
           and/or gp100.

        5. Main study endpoints

      This is an exploratory study aiming to demonstrate proof of principle. The first study
      endpoints are in vivo immunological response induced in high risk uveal melanoma patients
      vaccinated with mRNA-transfected DC, administered i.v./i.d. and toxicity. Secondary study
      endpoints are progression free survival, overall survival, and toxicity.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

immunological response

Secondary Outcome

 clinical response (progression free survival)

Condition

Uveal Melanoma

Intervention

autologous dendritic cells electroporated with mRNA

Study Arms / Comparison Groups

 dendritic cell vaccination
Description:  HLA-A2.1 positive patient will receive 3 biweekly intradermal/intravenous vaccination with autologous mRNA transfected mature dendritic cells, followed by a DTH skin test for monitoring purposes. One such cycle is repeated every 6 months if no signs of progression, up to a total of 3 cycles.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

23

Start Date

June 2009

Completion Date

April 2016

Primary Completion Date

April 2016

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Cornelis JA Punt, prof.MD, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT00929019

Organization ID

NL22553.000.08

Secondary IDs

KUN2008-035

Responsible Party

Sponsor

Study Sponsor

Radboud University

Collaborators

 Rotterdam Eye Hospital

Study Sponsor

Cornelis JA Punt, prof.MD, Principal Investigator, Radboud University Nijmegen Medical Centre, Dept of Medical Oncology

Verification Date

September 2015