Vaccination with dendritic cells (DC) obtained from blood and loaded with fluorine particles and proteins derived from tumor cells of patients with stage III melanoma in whom a radical lymph node dissection is planned, and visualization of migration in vivo
- Conditions
- melanoma patients with regional lymph node metastases (stage III)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2010-023757-11-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
-stage III melanoma with enlarged lymph nodes according to the 2001 AJCC criteria
- cytological or histological documented evidence of stage III melanoma
- HLA-A2.1 positive
- WHO performance status 0-1 (Karnofsky 100-70)
- life expectancy =3 months
- age 18-75 years
- no clinical signs or symptoms of CNS metastases
- WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, serum creatinine <150 µmol/l, serum bilirubin <25 µmol/l
- normal serum LDH (=250 U/l)
- expected adequacy of follow-up
- no pregnant or lactating women
- written informed consent
- radical regional lymphnode dissection is scheduled, but not yet performed
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- any prior chemotherapy, immunotherapy or radiotherapy is allowed if completed
more than 4 weeks prior to planned vaccination
- 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, known 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 symptomatic disease
- acute kidney injury or chronic severe kidney disease
- any serious clinical condition that may interfere with the safe administration of DC
- expected adequacy of follow-up
- no pregnant or lactating women
- written informed consent
- radical regional lymphnode dissection is scheduled
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method