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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00806728
First received: December 10, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Cancer
Graft-Versus-Host Disease
Drug: MEDI-507
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics [ Time Frame: Study Days 12 and 44 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: May 1998
Study Completion Date: December 1998
Primary Completion Date: November 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-507
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
MEDI-507
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806728

Locations
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
Investigators
Study Director: J. Bruce McClain, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: J. Bruce McClain, M.D., Medimmune Inc.
ClinicalTrials.gov Identifier: NCT00806728     History of Changes
Other Study ID Numbers: MI-CP042
Study First Received: December 10, 2008
Last Updated: December 10, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014