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Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in 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: NCT00243529
Recruitment Status : Completed
First Posted : October 24, 2005
Last Update Posted : September 29, 2009
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by:
Radboud University Medical Center

Tracking Information
First Submitted Date  ICMJE October 21, 2005
First Posted Date  ICMJE October 24, 2005
Last Update Posted Date September 29, 2009
Study Start Date  ICMJE April 2004
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Immune response [ Time Frame: first 10 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2005)
Immune response
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Safety [ Time Frame: first 10 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2005)
Safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma Stage III or IV
Intervention  ICMJE Biological: autologous dendritic cell vaccine
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: 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
    Intervention: Biological: autologous dendritic cell vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2009)
64
Original Enrollment  ICMJE
 (submitted: October 21, 2005)
40
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

For both stage III and IV

  • Histological proof of cutaneous melanoma
  • Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining,
  • HLA type A2 and/or A3, with known HLA-DR4 expression,
  • WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l.
  • Expected adequacy of follow-up,
  • Written informed consent.

For Stage III only

  • Stage III melanoma according to the 2001 AJCC criteria.
  • Start of treatment within 2 months of lymph node dissection for melanoma stage III

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

  • No autoimmune disorders, no concomitant use of immunosuppressive drugs,
  • no serious concomitant disease, no serious active infections, no 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,
  • No known allergy to shell fish (contains KLH) are excluded.
  • No pregnancy or lactation,

For stage III only:

  • No signs or symptoms of distant metastases as defined by normal history, physical examination, chest X-ray and serum LDH.
  • No concomitant or previous systemic treatment for melanoma

For stage IV only:

  • No 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.
  • No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00243529
Other Study ID Numbers  ICMJE 2003-2917
KWF 2003-2917
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof. C.J.A. Punt, MD, PhD, Radboud University Nijmegen Medical Centre
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Radboud University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Dutch Cancer Society
Investigators  ICMJE
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
PRS Account Radboud University Medical Center
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP