Melanoma
Conditions
Brief summary
This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.
Detailed description
Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.
Interventions
DRUGA: myDC vaccination
DRUGB: pDC vaccination
DRUGC: combined myDC/pDC vaccination
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* stage III melanoma * WHO performance status 0-1 * radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment
Exclusion criteria
* irresectable disease * any concurrent adjuvant therapy * concomitant use of oral immunosuppressive drugs * autoimmune diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| immunogenicity - type I IFN | up to 1.5 years | Type I IFN gene expression in PBMC shortly after vaccination. The occurrence of the type I IFN response in patients will be compared between the arms. |
| immunogenicity - response to KLH | up to 1.5 years | Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms. |
| immunogenicity - T cells in DTH | up to 1.5 years | Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0 | up to 1.5 years | Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0 |
| progression-free survival | 5 years | time from radical lymph node dissection to recurrence of (distant) disease |
| quality of life | 5 years | To assess the quality of life the EORTC QLQ-C30 questionnaire will be used. |
| overall survival | 5 years | time from radical lymph node dissection to death |
| biodistribution/localization of pDC and myDC in the lymph node | within 1 week after vaccination 1 | biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques |
Countries
Netherlands
Outcome results
None listed