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

NCT00929019 | Terminated Phase 1

• 2 other identifiers: NL22553.000.08KUN2008-035
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Rationale
2. 2.Objectives
3. 3.Study design
4. 4.Study population
5. 5.Main study endpoints

Conditions

Uveal Melanoma

Keywords

uveal melanoma; chromosome 3; high risk; immunotherapy; adjuvant; high risk genetic profile; loss of chromosome 3

Outcome Measures

Primary Outcomes (1)

• immunological response

  2 years

Secondary Outcomes (1)

• clinical response (progression free survival)

  5 years

Study Arms (2)

dendritic cell vaccination

EXPERIMENTAL

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.

Biological: autologous dendritic cells electroporated with mRNA

control arm

NO INTERVENTION

For comparison, HLA-A2.1 negative patients will be monitored for clinical response (secondary endpoint).

Interventions

autologous dendritic cells electroporated with mRNA BIOLOGICAL

Autologous mature monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase are vaccinated intradermal/intravenously 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations.

dendritic cell vaccination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Rotterdam Eye Hospital: collaborator

Study Sites (2)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

Location

The Rotterdam Eye Hospital

Rotterdam, South Holland, 3000LM, Netherlands

Location

Related Links

• Radboud University Nijmegen Medical Centre
• Rotterdam Eye Hospital

MeSH Terms

Conditions

Uveal Melanoma

Interventions

RNA, Messenger

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

RNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Cornelis JA Punt, prof.MD

  Radboud University Nijmegen Medical Centre, Dept of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 7, 2018

Record last verified: 2015-09

Locations

NL (2)