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

Advanced HCC Clinical Trial

Official title:

Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396682
• Other study ID #: HAN-HCC-002
• Secondary ID: DFG - KFO 119
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2006
• Last updated: February 3, 2009
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adequate WBC

• adequate liver and kidney function

• no immunodeficiency

• ECOG < 2

Exclusion Criteria:

• advanced liver cirrhosis

• severe cardiopulmonary diseases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced HCC

Intervention

Drug:
• Cyclophosphamide
150 - 250 - 350 mg

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of CD4+CD25+regulatory T cells		within 8 weeks	No
Primary	Tumor specific immune responses		within 12 weeks	No
Secondary	Toxicity		within 8 weeks	Yes
Secondary	Function and Phenotype of CD4+CD25+ regulatory T cells		within 12 weeks	No
Secondary	Tumor response		within 12 weeks	No
Secondary	Survival		6 months	No