Efalizumab in Treating Patients With Graft-Versus-Host Disease of the Skin That Did Not Respond to Previous Steroids — NRR  

Graft Versus Host Disease Clinical Trial

Official title: Weekly Subcutaneous Efalizumab for the Treatment of Steroid Refractory Graft-Versus-Host Disease of the Skin and Liver

Status Terminated

Clinical Trial Summary

RATIONALE: Efalizumab may be an effective treatment for graft-versus-host disease of the skin caused by a donor stem cell transplant.

PURPOSE: This clinical trial is studying the side effects and how well efalizumab works in treating patients with graft-versus-host disease of the skin that did not respond to previous steroids.

Clinical Trial Description

OBJECTIVES:

Primary

• Assess the general safety of efalizumab in patients with cutaneous graft-vs-host disease (GVHD).

• Study the feasibility of digital imaging to objectively quantify cutaneous GVHD.

• Evaluate the feasibility of serial skin biopsies to monitor disease response to efalizumab in patients with cutaneous GVHD.

Secondary

• Assess the overall complete response rate in patients treated with this drug.

• Assess the overall cutaneous response rate (complete cutaneous response rate and partial cutaneous response rate) in patients treated with this drug.

• Assess the overall hepatic response rate (complete hepatic response rate and partial hepatic response rate) in patients treated with this drug.

• Assess the duration of any responses observed.

• Assess the effect of this drug on overall patient survival.

• Use the preliminary efficacy and toxicity data collected in this small exploratory study to decide on the appropriateness of a larger, subsequent phase II trial to more formally assess toxicity and efficacy of this drug in this patient population.

• Collect pharmacokinetic data on this drug in these patients.

OUTLINE: Patients receive efalizumab subcutaneously once weekly for 8 weeks (total of 8 doses).

Digital photographs of body regions are taken for determination of disease involved body surface area. Skin biopsies are obtained before and after treatment and analyzed for LFA-1, ICAM-1, CD4, CD8, and possibly CD20 by immunohistochemistry.

After completion of study therapy, patients are followed at 1 and 9 weeks. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

• NCT number: NCT00489216
• Study type: Interventional
• Source: UNC Lineberger Comprehensive Cancer Center
• Status: Terminated
• Phase: N/A
• Start date: December 2006
• Completion date: October 2008