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Dendritic Cell Based Therapy of Malignant Melanoma

This study is ongoing, but not recruiting participants.

Sponsored by: Herlev Hospital
Information provided by: Herlev Hospital
ClinicalTrials.gov Identifier: NCT00197912
  Purpose

The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.


Condition Intervention Phase
Advanced Melanoma
Biological: tumor antigen loaded autologous dendritic cells
Phase I
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma.Phase I/II Study.

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Primary aim of the study is to evaluate tolerability and safety of the treatment [ Time Frame: weekly the first four weeks thereafter biweekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary aims: evaluation of treatment induced immune response and clinical response. [ Time Frame: after 8 and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   September 2004
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Biological: tumor antigen loaded autologous dendritic cells
    DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with p53, survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate pulsed dendritic cells.From the 2nd vaccine, 2 MIU Interleukin-2 is administered sc on day 2-6.
Detailed Description:

Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by either intranodal or intradermal injection near the inguinal region. For adjuvant used IL-2 2 MIU sc. day 2-6 and Interferon-alpha 2b, 3 MIU sc daily day 1-6 is used. Scans and re-staging tests are performed at scheduled intervals throughout the study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histologically proven progressive metastatic or locally advanced melanoma
  • No standard treatment indicated
  • Age: > 18
  • WHO-Performance Status 0-1
  • At least tone measurable tumor lesions according to the RECIST criteria.
  • Life expectancy more than 3 months
  • Acceptable CBC and blood chemistry results
  • Written informed consent

Exclusion Criteria:

  • Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
  • Patients with metastatic disease in the central nervous system (CNS).
  • Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
  • Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
  • Patients who are pregnant.
  • Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
  • Patients who receive corticosteroids or other immunosuppressive agents.
  • Baseline serum LDH greater than 2.5 times the upper limit of normal.
  • Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197912

Locations
Denmark
Department of Oncology, Copenhagen University Hospital, Herlev    
      Herlev, Denmark, 2970

Sponsors and Collaborators
Herlev Hospital

Investigators
Principal Investigator:     Inge Marie Svane, MD, PHD     Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark    
  More Information

Publications:

Responsible Party:   Department of Oncology, Herlev Hospital ( Inge Marie Svane, MD, PhD )
Study ID Numbers:   MM0413
First Received:   September 12, 2005
Last Updated:   January 2, 2008
ClinicalTrials.gov Identifier:   NCT00197912
Health Authority:   Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
dendritic cell  
cancervaccine  
melanoma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Interleukin-2
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 21, 2008




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