Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00806728
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : December 11, 2008
Information provided by:
MedImmune LLC

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.

Condition or disease Intervention/treatment Phase
Cancer Graft-Versus-Host Disease Drug: MEDI-507 Phase 1

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 to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease
Study Start Date : May 1998
Actual Primary Completion Date : November 1998
Actual Study Completion Date : December 1998

Arm Intervention/treatment
Experimental: 1
Drug: MEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
Experimental: 2
Drug: MEDI-507
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37.

Primary Outcome Measures :
  1. Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs. [ Time Frame: Day 0-60 ]

Secondary Outcome Measures :
  1. Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics [ Time Frame: Study Days 12 and 44 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00806728

United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Oklahoma
University Hospital-University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Western Pennsylvania Hospital - Western Pennsylvania Cancer Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
South Texas Cancer Institute at Methodist Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
MedImmune LLC
Study Director: J. Bruce McClain, M.D. MedImmune LLC

Responsible Party: J. Bruce McClain, M.D., Medimmune Inc. Identifier: NCT00806728     History of Changes
Other Study ID Numbers: MI-CP042
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases