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

NCT ID: NCT00396682

Last Updated: 2009-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced HCC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cyclophosphamide

150 - 250 - 350 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* advanced liver cirrhosis
* severe cardiopulmonary diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Med. Hochschule Hannover

Principal Investigators

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Tim F Greten, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Medizinische Hochschule Hannover

Tim F Greten, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 20139774 (View on PubMed)

Other Identifiers

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DFG - KFO 119

Identifier Type: -

Identifier Source: secondary_id

HAN-HCC-002

Identifier Type: -

Identifier Source: org_study_id

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