Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD
N/A
N/A
Both
Graft Versus Host Disease
Trial Information
Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD
OBJECTIVES:
- Determine the survival rate at 180 days after treatment with visilizumab (Nuvion) as
second-line therapy in patients with glucocorticoid-refractory acute graft-versus-host
disease after prior allogeneic hematopoietic stem cell transplantation.
- Determine the safety of this drug in these patients.
- Determine the clinical response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive visilizumab (Nuvion) IV for 1-2 doses.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of grade II-IV acute graft-versus-host disease (GVHD) meeting 1 of the
following criteria:
- Progressive GVHD after receiving methylprednisolone (MePRDL) at a minimum dose
of 2 mg/kg for 3 days
- Persistent grade III or IV GVHD after receiving MePRDL and cyclosporine (CYSP)
or tacrolimus (FK506) for 7 days
- Persistent grade II GVHD after receiving MePRDL and CYSP or FK506 for 14 days
- Must meet at least 1 of the following criteria:
- Evaluable skin rash
- Evaluable diarrhea
- Abdominal pain and cramping
- Evaluable hyperbilirubinemia in the absence of clinically defined veno-occlusive
disease, viral hepatitis, or structural abnormalities, as indicated on either
liver ultrasound or CT scans
- Received prior allogeneic hematopoietic stem cell transplantation
- Patients continue GVHD prophylaxis with CYSP or FK506 at the dose tolerated by renal
function
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Karnofsky 30-100% OR
- Lansky 30-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- See Disease Characteristics
Renal:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- Not specified
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
James Lowder, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Facet Biotech
Authority:
United States: Federal Government
Study ID:
CDR0000069416
NCT ID:
NCT00042744
Start Date:
March 2002
Completion Date:
Related Keywords:
- Graft Versus Host Disease
- graft versus host disease
- Graft vs Host Disease
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| Siteman Cancer Center | Saint Louis, Missouri 63110 |
