Single-step antigen loading and TLR activation of dendritic cells by mRNA electroporation for vaccination in stage III and IV melanoma patients - Trimix DC vaccinations in melanoma patients

• Conditions: Our study population consists of melanoma patients, with proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is planned or performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.

• Registration Number: EUCTR2009-015737-73-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

For both stage III and IV melanoma
- histologically documented evidence of melanoma
- stage III or IV melanoma according to the 2001 AJCC criteria
- HLA-A2.1 phenotype is required
- melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
- WHO performance status 0-1 (Karnofsky 100-70%)
- life expectancy >3 months
- age 18-70 years
- no clinical signs or symptoms of CNS metastases
- 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
- normal serum LDH (=450 U/l)
- expected adequacy of follow-up
- no pregnant or lactating women
- written informed consent
For stage III melanoma
- interval since regional lymph node dissection is <2 months
For stage IV melanoma
- at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and limited tumor burden, according to the responsible physician
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

- prior chemotherapy, immunotherapy or radiotherapy <4 weeks prior to planned
vaccination or presence of treatment-related toxicity
- history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
serious active infections, HbsAg or HIV positive or autoimmune diseases or organ allografts
- concomitant use of immunosuppressive drugs
- known allergy to shell fish (since it contains KLH)
- rapidly progressive disease
- any serious clinical condition that may interfere with the safe administration of DC

Study & Design

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