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Plasmacytoid Dendritic Cell Vaccines in Metastatic Melanoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Winette van der Graaf, Radboud University
ClinicalTrials.gov Identifier:
NCT01690377
First received: February 5, 2008
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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). To date PDC 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 in stage IV melanoma patients.


Condition Intervention Phase
Melanoma
Biological: PDC
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • intervention-related toxicity [ Time Frame: Within the first 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Immunological response [ Time Frame: Within the first year ] [ Designated as safety issue: No ]
    The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination


Enrollment: 30
Study Start Date: February 2008
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PDC
Biological: PDC
PDC; first patient 0.3 * 10E6 PDC; second and third 1 * 10E6 PDC; fourth and fifth 3 * 10E6 PDC.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690377

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: C J A Punt, MD, PhD Radboud University
Principal Investigator: C G Figdor, PhD Radboud University Nijmegen Medical Centre / Nijmegen Centre for Molecular Life Sciences
  More Information

No publications provided

Responsible Party: Prof. Dr. Winette van der Graaf, professor, Radboud University
ClinicalTrials.gov Identifier: NCT01690377     History of Changes
Other Study ID Numbers: 2004-093, KWF 2004-3127
Study First Received: February 5, 2008
Last Updated: November 4, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Dendritic Cells

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 24, 2014