NCT00489216

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 lymphocyte function associated antigen (LFA-1), intercellular adhesion molecule (ICAM-1), cluster of differentiation 4, 8, and possibly 20 (CD4, CD8, CD20) by immunohistochemistry. After completion of study therapy, patients are followed at 1 and 9 weeks.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	efalizumab	Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at 1mg/kg

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2007-06-21
• Last updated: 2017-05-23
• Results posted: 2017-04-06

Locations

1 site across 1 country: United States