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| Sponsor: | Radboud University |
|---|---|
| Collaborator: |
Dutch Cancer Society |
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00243529 |
Purpose
Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as such they are able to direct the immune system specifically against cancer cells. Currently DCs are used in clinical vaccination studies and immunological and clinical responses have been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen (i.e. molecular structures that are presented by the tumor, that are recognized by the immune system). Currently most studies use tumor peptides (small protein fragments) for this purpose. This approach has several disadvantages: only patients with a certain HLA-type can be treated and the immune response that is induced by the vaccine is limited to the used peptides. These disadvantages do not exist when the DCs present antigen which is endogenously processed, for example after RNA transfection. For this reason we investigate the immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding melanoma associated antigens in stage III and IV melanoma patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Stage III or IV |
Biological: autologous dendritic cell vaccine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | In Vivo Responses of DC Vaccines Presenting HLA Class I and II Restricted Tumor Epitopes Either by Peptide-pulsing or mRNA Transfection in Melanoma Patients |
| Enrollment: | 64 |
| Study Start Date: | April 2004 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: MHC Class I restricted epitopes
HLA-A2.1 patients are vaccinated with dendritic cells loaded with MHC Class I restricted epitopes of tumor antigens gp100 and tyrosinase
|
Biological: autologous dendritic cell vaccine |
|
Experimental: MHC Class I and II restricted epitopes
HLA-A2.1 and HLA-DR4 patients are vaccinated with dendritic cells loaded with MHC Class I and II restricted epitopes of tumor antigens gp100 and tyrosinase
|
Biological: autologous dendritic cell vaccine |
|
Experimental: mRNA transfected DC
HLA-A2.1 and/or HLA-DR4 patients are vaccinated with dendritic cells transfected with mRNA encoding tumor antigens gp100 and tyrosinase
|
Biological: autologous dendritic cell vaccine |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For both stage III and IV
For Stage III only
For stage IV only
-Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal
Exclusion Criteria:
For both stage III and IV
For stage III only:
For stage IV only:
Contacts and Locations| Netherlands | |
| Radboud University Nijmegen Medical Center | |
| Nijmegen, PO Box 9101, Netherlands, 6500 HB | |
| Principal Investigator: | Prof. C.J.A. Punt, MD, PhD | Radboud University Nijmegen Medical Center |
| Principal Investigator: | Prof. G.J. Adema, PhD | Radboud University Nijmegen Medical Center/Nijmegen Center for Molecular Life Sciences |
More Information
| Responsible Party: | Prof. C.J.A. Punt, MD, PhD, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00243529 History of Changes |
| Other Study ID Numbers: | 2003-2917, KWF 2003-2917 |
| Study First Received: | October 21, 2005 |
| Last Updated: | September 28, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Dendritic cells Melanoma Vaccine |
Immunotherapy RNA Peptides |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |