mRNA-transfected dendritic cell vaccination in high risk uveal melanoma patients
- Conditions
- melanoma of the eye10030054
- Registration Number
- NL-OMON33733
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
- histologically documented evidence of uveal melanoma
- HLA-A02.01 phenotype is required for treatment group
- 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-abdomen
- normal serum LDH
- 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
- 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 (test only in case of high risk or
clinical suspicion)
- autoimmune diseases or organ allografts
- concomitant use of immunosuppressive drugs
- known allergy to shell fish (since it contains KLH)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In vivo immune response to the tumor associated antigens in at least 16 out of<br /><br>31 patients will be considered as a positive result.</p><br>
- Secondary Outcome Measures
Name Time Method <p> An improvement in disease-free survival > 95 months as compared with the<br /><br>control group (arm B) will be considered a positive end result.</p><br>