search
Back to results

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
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 30, 2015
Last Updated
September 13, 2021
Sponsor
Radboud University Medical Center
search

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

We'll reach out to this number within 24 hrs