Plasmacytoid Dendritic Cell Vaccines in Metastatic Melanoma Patients
This study is currently recruiting participants.
Verified September 2012 by Radboud University
Sponsor:
Radboud University
Information provided by (Responsible Party):
Prof. Dr. Winette van der Graaf, Radboud University
ClinicalTrials.gov Identifier:
NCT01690377
First received: February 5, 2008
Last updated: September 18, 2012
Last verified: September 2012
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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
| Estimated Enrollment: | 5 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690377
Contacts
| Contact: E Aarntzen, MD | +31-243610550 | E.Aarntzen@aig.umcn.nl |
| Contact: C J A Punt, MD, PhD | +31-243610353 | c.punt@onco.umcn.nl |
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| 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: | September 18, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Radboud University:
|
Dendritic Cells |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 16, 2013