Elimination of CD4+CD25+ Regulatory T Cells in HCC Patients - Full Text View

Sponsored by:	Hannover Medical School
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00396682

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 III

MedlinePlus related topics: Cancer

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Tim F Greten, MD

0511 532 ext 6760

greten.tim@mh-hannover.de

Locations

Germany
Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, 30655
Contact: Tim Greten 0511 5320 greten.tim@mh-hannover.de
Principal Investigator: Tim F Greten, M.D.
Principal Investigator: Firouzeh Korangy, Ph.D.

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

Responsible Party:	Med. Hochschule Hannover ( Tim Greten )
Study ID Numbers:	HAN-HCC-002, DFG - KFO 119
Study First Received:	November 6, 2006
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00396682
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

HCC
T cell

Study placed in the following topic categories:

Cyclophosphamide

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists

Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009