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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
  Purpose

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.


Condition Intervention Phase
Advanced HCC
Drug: Cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cyclophosphamide
    150 - 250 - 350 mg
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • advanced liver cirrhosis
  • severe cardiopulmonary diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396682

Locations
Germany
Medizinische Hochschule Hannover
Hannover, Germany, 30655
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Tim F Greten, M.D. Department of Gastroenterology, Medizinische Hochschule Hannover
Principal Investigator: Tim F Greten, M.D. Hannover Medical School
  More Information

No publications provided by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tim Greten, Med. Hochschule Hannover
ClinicalTrials.gov Identifier: NCT00396682     History of Changes
Other Study ID Numbers: HAN-HCC-002, DFG - KFO 119
Study First Received: November 6, 2006
Last Updated: February 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
HCC
T cell

Additional relevant MeSH terms:
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014