Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

December 7, 2016 updated by: Radboud University Medical Center

Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PDC or myDC
Biological: PDC or myDC
PDC or myDC; first patient 0.3 * 10E6 PDC; second and third 1 * 10E6 PDC; fourth and fifth 3 * 10E6 PDC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intervention-related toxicity
Time Frame: 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
Within the first 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological response
Time Frame: Within the first year
The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination
Within the first year

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: C J A Punt, MD, PhD, Radboud University Medical Center
  • Principal Investigator: C G Figdor, PhD, Radboud University Nijmegen Medical Centre / Nijmegen Centre for Molecular Life Sciences

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

February 1, 2008

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-093
  • KWF 2004-3127

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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