mRNA-transfected dendritic cell vaccination in high risk uveal melanoma patients - mRNA-DC vaccination in uveal melanoma

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2008-001974-33-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-25
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <12 months
- no signs of liver metastasis as determined by diagnostic CT-scan abdomen
- normal serum LDH
- WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l,
serum crea-tinine <150 µmol/l, serum bilirubin <25 µmol/l
- no clinical signs of CNS metastases
- WHO performance status 0-1 (Karnofsky 100-70%)
- life expectancy >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

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified