myDC/pDC in Stage III Melanoma Patients
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
A: myDC vaccination
B: pDC vaccination
C: combined myDC/pDC vaccination
Sponsored by

About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
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
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A: myDC vaccination
B: pDC vaccination
C: combined myDC/pDC vaccination
Arm Description
intranodal injection with tumor peptide-loaded myeloid dendritic cells
intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells
intranodal injection with tumor peptide-loaded myeloid and plasmacytoid dendritic cells
Outcomes
Primary Outcome Measures
immunogenicity - type I IFN
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
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
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 Outcome Measures
biodistribution/localization of pDC and myDC in the lymph node
biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques
safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
quality of life
To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.
progression-free survival
time from radical lymph node dissection to recurrence of (distant) disease
overall survival
time from radical lymph node dissection to death
Full Information
NCT ID
NCT02574377
First Posted
September 30, 2015
Last Updated
September 13, 2021
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02574377
Brief Title
myDC/pDC in Stage III Melanoma Patients
Official Title
Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
September 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: myDC vaccination
Arm Type
Experimental
Arm Description
intranodal injection with tumor peptide-loaded myeloid dendritic cells
Arm Title
B: pDC vaccination
Arm Type
Experimental
Arm Description
intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells
Arm Title
C: combined myDC/pDC vaccination
Arm Type
Experimental
Arm Description
intranodal injection with tumor peptide-loaded myeloid and plasmacytoid dendritic cells
Intervention Type
Drug
Intervention Name(s)
A: myDC vaccination
Intervention Type
Drug
Intervention Name(s)
B: pDC vaccination
Intervention Type
Drug
Intervention Name(s)
C: combined myDC/pDC vaccination
Primary Outcome Measure Information:
Title
immunogenicity - type I IFN
Description
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.
Time Frame
up to 1.5 years
Title
immunogenicity - response to KLH
Description
Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms.
Time Frame
up to 1.5 years
Title
immunogenicity - T cells in DTH
Description
Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms.
Time Frame
up to 1.5 years
Secondary Outcome Measure Information:
Title
biodistribution/localization of pDC and myDC in the lymph node
Description
biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques
Time Frame
within 1 week after vaccination 1
Title
safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Description
Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Time Frame
up to 1.5 years
Title
quality of life
Description
To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.
Time Frame
5 years
Title
progression-free survival
Description
time from radical lymph node dissection to recurrence of (distant) disease
Time Frame
5 years
Title
overall survival
Description
time from radical lymph node dissection to death
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winald Gerritsen
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
myDC/pDC in Stage III Melanoma Patients
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