Status:
COMPLETED
The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Graft-Versus-Host Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Etanercept (Enbrel) will be added to standard therapy for acute Graft-versus-Host Disease to see if the effectiveness of standard therapy can be improved. Partial Funding Source- FDA OOPD
Detailed Description
The standard treatment for acute graft-versus-host disease is a combination of steroids and tacrolimus or cyclosporine. Previous work has shown that less than 50% of patients respond fully to GVHD. Wi...
Eligibility Criteria
Inclusion
- Patient may be transplanted with stem cells from any source using either a myeloablative or nonmyeloablative preparative regimen
- Patient may be any age
- Patient must have biopsy proven new onset of aGVHD; Clinical Grading must be II-IV and may occur after stem cell transplant or donor leukocyte infusion (DLI). Patients may begin Etanercept treatment prior to biopsy confirmation of GVHD. Acute GVHD will be determined by clinical presentation and not timing from stem cell infusion
- Patient must be on solumedrol at a dose of 2mg/kg/day of actual body weight for no more than 72 hours prior to the initiation of etanercept
- Patient must have evidence of neutrophil engraftment with an ANC of \> 500 for three consecutive days
- Pulse ox \> 90% on room air
Exclusion
- Pregnancy or nursing mother
- Intolerance or allergic reaction to etanercept
- Previous use of steroids for treatment of acute GVHD
- Active infection, chronic or localized, not responding to antibiotics, with continued signs of infection (patients with a positive C. Difficile test will not be excluded from the study)
- Condition that might predispose to developing serious infections (i.e. active and uncontrolled diabetes mellitus, sickle cell anemia)
- Other investigational agents for the treatment or prophylaxis of graft-vs-host disease within the past 2 weeks
- Serum creatinine \> 2.0mg/dl
- Patients being treated for acute pulmonary dysfunction (IPS) study using etanercept
- Patients with hypotension believed to be secondary to sepsis syndrome or heart failure requiring \> 1 inotropic agent, or dopamine \>5mcg/kg/minute for blood pressure support
- Evidence of congestive heart failure on clinical exam
- Evidence of hepatic dysfunction with an ALT or AST \> 2.5 x ULN, not due to GVHD
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00141713
Start Date
October 1 2003
End Date
December 1 2006
Last Update
March 13 2013
Active Locations (1)
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1
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109