Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00396682
First received: November 6, 2006
Last updated: February 3, 2009
Last verified: February 2009

November 6, 2006
February 3, 2009
February 2007
December 2008   (final data collection date for primary outcome measure)
  • Frequency of CD4+CD25+regulatory T cells [ Time Frame: within 8 weeks ] [ Designated as safety issue: No ]
  • Tumor specific immune responses [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]
  • Frequency of CD4+CD25+regulatory T cells
  • Tumor specific immune responses
Complete list of historical versions of study NCT00396682 on ClinicalTrials.gov Archive Site
  • Toxicity [ Time Frame: within 8 weeks ] [ Designated as safety issue: Yes ]
  • Function and Phenotype of CD4+CD25+ regulatory T cells [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Toxicity
  • Function and Phenotype of CD4+CD25+ regulatory T cells
  • Tumor response
  • Survival
Not Provided
Not Provided
 
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide

It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+ regulatory T cells. These cells might suppress tumor-specific immune responses. Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses in patients with advanced HCC.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced HCC
Drug: Cyclophosphamide
150 - 250 - 350 mg
Not Provided
Greten TF, Ormandy LA, Fikuart A, Höchst B, Henschen S, Hörning M, Manns MP, Korangy F. Low-dose cyclophosphamide treatment impairs regulatory T cells and unmasks AFP-specific CD4+ T-cell responses in patients with advanced HCC. J Immunother. 2010 Feb-Mar;33(2):211-8. doi: 10.1097/CJI.0b013e3181bb499f.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adequate WBC
  • adequate liver and kidney function
  • no immunodeficiency
  • ECOG < 2

Exclusion Criteria:

  • advanced liver cirrhosis
  • severe cardiopulmonary diseases
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00396682
HAN-HCC-002, DFG - KFO 119
Not Provided
Tim Greten, Med. Hochschule Hannover
Hannover Medical School
Not Provided
Principal Investigator: Tim F Greten, M.D. Department of Gastroenterology, Medizinische Hochschule Hannover
Principal Investigator: Tim F Greten, M.D. Hannover Medical School
Hannover Medical School
February 2009

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