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Home > "V" Clinical Trials Conditions > Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation  Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation
Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation
For Condition: Graft Versus Host Disease
Status: No longer recruiting
Sponsor(s): Protein Design Labs ,
Synopsis: RATIONALE: Visilizumab may suppress the immune system and may be an effective treatment for graft-versus-host disease caused by donor peripheral stem cell transplantation. PURPOSE: Phase II trial to study the effectiveness of visilizumab in treating patients who have graft-versus-host disease following donor peripheral stem cell transplantation that has not responded to previous treatment.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesLowder, Study Chair, Protein Design Labs
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6310
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000069416; PDL-1589
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042744
Other Graft Versus Host Disease Studies:
1. Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
2. Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
3. Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic Disorders
4. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
5. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
Related Studies:
Other Graft Versus Host Disease Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation
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