Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000294

Trial Description

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Title

Phase I study of a gene modified, B7/IL-7-transfected allogeneic tumor cell vaccine for the treatment of metastatic renal cell carcinoma

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Trial Acronym

-

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URL of the Trial

http://-

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Brief Summary in Lay Language

Phase I study of gene-modified (B7.1/IL-7-transfected) tumor cells as a vaccine in patients with metastatic renal cell cancer.

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Brief Summary in Scientific Language

Phase I study to evaluate feasibility and safety as well as analysis of specific immune response after vaccination with gene-modified (B7.1/IL-7-transfected) tumor cells.

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Organizational Data

  •   DRKS00000294
  •   2010/03/10
  •   [---]*
  •   yes
  •   Approved
  •   AA3/00/29, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1112-9598 
  •   DeReG-Nr: 43  (Deutsches Register für somatische Gentransferstudien)
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Health Condition or Problem studied

  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   I
  •   [---]*
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Primary Outcome

-Feasibility and safety of the vaccination
-Assessment of a specific t-cell response

Acute and long-term toxicity will be assesssed by adverse event reports, clinical evaluation and review of laboratoray studies and immunological parameters.
The t cell response will be assessed by T cell receptor analysis, ELISPOT assay.

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Secondary Outcome

-Clinical outcome

Clinical outcome will be assessed by clinical examination and CT scans at fixed timepoints.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2005/02/02
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

-histologically proven renal cell carcinoma
-age between 18 and 75
-HLA-A0201-positive patients
-adequate performance status
-life expectancy over 3 months
-interval to last therapy >4 weeks
-one evaluable marker lesion
-written informed consent

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Exclusion Criteria

-pregnancy oder nursing, missing contraception
-evidence of autoimmune disease
-history of severe allergy
-systemic corticosteroid therapy or other immunosuppressive therapy
-patients with organ allografts
-HIV positivity
-active infection or severe disease
-active brain lesions
-impaired renal-, liver - oder hematological function
-evidence or history of malignant disease in the past five years
-use of unapproved biologic agents (mistletoe, live cells)

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Addresses

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    • Medizinische Klinik für Hämatologie, Onkologie Charité, Campus Virchow
    • Mr.  Prof. Dr. med.  Antonio  Pezzutto 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
    • Mr.  Prof. Dr.  Antonio  Pezzutto 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   +49-30-450553192
    •   -
    •   -
    •   [---]*
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    • Charité Campus Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
    • Ms.  Dr. med.  Anne  Flörcken 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • BMBF: Bundesministerium für Bildung und Forschung
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.