myDC/pDC in Stage III Melanoma Patients

September 13, 2021 updated by: Radboud University Medical Center

Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: myDC vaccination
intranodal injection with tumor peptide-loaded myeloid dendritic cells
Drug: A: myDC vaccination
Experimental: B: pDC vaccination
intranodal injection with tumor peptide-loaded plasmacytoid dendritic cells
Drug: B: pDC vaccination
Experimental: C: combined myDC/pDC vaccination
intranodal injection with tumor peptide-loaded myeloid and plasmacytoid dendritic cells
Drug: C: combined myDC/pDC vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunogenicity - type I IFN
Time Frame: 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.
up to 1.5 years
immunogenicity - response to KLH
Time Frame: 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.
up to 1.5 years
immunogenicity - T cells in DTH
Time Frame: 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.
up to 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biodistribution/localization of pDC and myDC in the lymph node
Time Frame: within 1 week after vaccination 1
biodistribution/localization of the injected labeled pDC and/or myDC in the resected lymph node by multiple techniques
within 1 week after vaccination 1
safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
Time Frame: up to 1.5 years
Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
up to 1.5 years
quality of life
Time Frame: 5 years
To assess the quality of life the EORTC QLQ-C30 questionnaire will be used.
5 years
progression-free survival
Time Frame: 5 years
time from radical lymph node dissection to recurrence of (distant) disease
5 years
overall survival
Time Frame: 5 years
time from radical lymph node dissection to death
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Winald Gerritsen, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49528.000.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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