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Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01690377
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: PDC or myDC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study
Study Start Date : February 2008
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690377


Locations
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Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
Investigators
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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
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT01690377    
Other Study ID Numbers: 2004-093
KWF 2004-3127
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: November 2014
Keywords provided by Radboud University Medical Center:
Dendritic Cells
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas