Melanoma
Conditions
Keywords
Dendritic Cells
Brief summary
Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. Several subsets of dendritic cells have been characterized in the peripheral blood. One such subset is referred to as plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC and myDC have not been evaluated for their capability to induce anti-tumor immune responses in patients. For this reason the investigators will perform a safety and efficacy study with PDC and myDC in stage IV melanoma patients.
Interventions
BIOLOGICALPDC or myDC
PDC or myDC; first patient 0.3 \* 10E6 PDC; second and third 1 \* 10E6 PDC; fourth and fifth 3 \* 10E6 PDC.
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH \< 2x upper limit of normal * Histological proof of cutaneous melanoma * Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more determined by immunohistochemistry staining) * HLA Type A2 * WBC \> 3.0 \* 10E9/l, lymphocytes \> 0.8 \* 10E9/l, platelets \> 100 \* 10E9/l, serum creatinine \< 150 umol/l, serum bilirubin \< 25 umol/l, normal liver function * Expected adequacy of follow up * Written informed consent
Exclusion criteria
* autoimmune disorders, concomitant use of immunosuppressive drugs * serious concomitant disease, serious active infections, other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin * known allergy to shell fish (vaccine contains KLH) * pregnancy or lactation * clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this * prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intervention-related toxicity | Within the first 6 months | all adverse events within a time frame of 3 weeks after the last vaccination will be scored according to Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological response | Within the first year | The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination |
Countries
Netherlands
Outcome results
None listed