Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation - Full Text View

Sponsored by:	PDL BioPharma, Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042744

Purpose

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.

Condition	Intervention	Phase
Graft Versus Host Disease	Biological: visilizumab	Phase II

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD

Resource links provided by NLM:

Drug Information available for: Visilizumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2002

Detailed Description:

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042744

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Missouri
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, New York
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

PDL BioPharma, Inc.

Investigators

Study Chair:

James Lowder, MD

Facet Biotech

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069416, PDL-1589
Study First Received:	August 5, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00042744 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

graft versus host disease

Study placed in the following topic categories:

Graft Versus Host Disease
Antibodies
Graft vs Host Disease

Glucocorticoids
Homologous Wasting Disease
Immunoglobulins

Additional relevant MeSH terms:

Immune System Diseases
Graft vs Host Disease

ClinicalTrials.gov processed this record on July 02, 2009