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

February 3, 2009 updated by: Hannover Medical School

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.

Study Overview

Status

Completed

Conditions

Advanced HCC

Intervention / Treatment

Drug: Cyclophosphamide

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Hannover, Germany, 30655
    - Medizinische Hochschule Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

advanced liver cirrhosis
severe cardiopulmonary diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of CD4+CD25+regulatory T cells Time Frame: within 8 weeks	within 8 weeks
Tumor specific immune responses Time Frame: within 12 weeks	within 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival Time Frame: 6 months	6 months
Toxicity Time Frame: within 8 weeks	within 8 weeks
Function and Phenotype of CD4+CD25+ regulatory T cells Time Frame: within 12 weeks	within 12 weeks
Tumor response Time Frame: within 12 weeks	within 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Greten TF, Ormandy LA, Fikuart A, Hochst B, Henschen S, Horning 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)