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Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD


Phase 2
N/A
N/A
Open (Enrolling)
Both
Graft Versus Host Disease

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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 MedicineHouston, Texas  77030
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Baylor University Medical CenterDallas, Texas  75246
Siteman Cancer CenterSaint Louis, Missouri  63110