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

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: NCT00396682
Recruitment Status : Completed
First Posted : November 7, 2006
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Advanced HCC Drug: Cyclophosphamide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide
Study Start Date : February 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Cyclophosphamide
    150 - 250 - 350 mg

Outcome Measures

Primary Outcome Measures :
  1. Frequency of CD4+CD25+regulatory T cells [ Time Frame: within 8 weeks ]
  2. Tumor specific immune responses [ Time Frame: within 12 weeks ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: within 8 weeks ]
  2. Function and Phenotype of CD4+CD25+ regulatory T cells [ Time Frame: within 12 weeks ]
  3. Tumor response [ Time Frame: within 12 weeks ]
  4. Survival [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Hannover Medical School:
HCC
T cell

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