Status:
COMPLETED
Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease
Lead Sponsor:
MedImmune LLC
Conditions:
Cancer
Graft-Versus-Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
Detailed Description
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response ...
Eligibility Criteria
Inclusion
- Allogeneic bone marrow or hematopoietic stem cell graft recipients
- Acute GVHD of at least grade II severity
- Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
- Evidence of engraftment (ANC over 1000 cells/mm3)
- Histologic evidence of GVHD from biopsy performed during the current episode
- Received GVHD prophylaxis of methotrexate, tacrolimus or cyclosporine
- Age at least 18 years
- Body weight under 130 kg
- Both males and females are eligible but females of childbearing potential will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)
Exclusion
- Previous receipt of MEDI-507
- Clinical or histologic manifestation of chronic GVHD
- Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
- Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
- More than one allogeneic bone marrow or hematopoietic stem cell allograft
- Moribund and unlikely (in the opinion of the investigator) to survive 15 days
- Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert)
- Any of the following clinical settings or diagnoses:
- Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
- Histologically confirmed veno-occlusive disease of the liver
- Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1998
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00806728
Start Date
May 1 1998
End Date
December 1 1998
Last Update
December 11 2008
Active Locations (10)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
3
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
4
Washington University Medical Center
St Louis, Missouri, United States, 63110