NCT00396682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

1.8 years

First QC Date

November 6, 2006

Last Update Submit

February 3, 2009

Conditions

Advanced HCC

Keywords

HCCT cell

Outcome Measures

Primary Outcomes (2)

  • Frequency of CD4+CD25+regulatory T cells

    within 8 weeks

  • Tumor specific immune responses

    within 12 weeks

Secondary Outcomes (4)

  • Toxicity

    within 8 weeks

  • Function and Phenotype of CD4+CD25+ regulatory T cells

    within 12 weeks

  • Tumor response

    within 12 weeks

  • Survival

    6 months

Interventions

CyclophosphamideDRUG

150 - 250 - 350 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • advanced liver cirrhosis
  • severe cardiopulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, 30655, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20139774DERIVED

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Tim F Greten, M.D.

    Department of Gastroenterology, Medizinische Hochschule Hannover

    PRINCIPAL INVESTIGATOR

  • Tim F Greten, M.D.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 7, 2006

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

DE(1)