search
Back to results

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

Primary Purpose

Cancer, Graft-Versus-Host Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI-507
MEDI-507
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope National Medical Center
  • University of Colorado Health Sciences Center
  • University of Michigan Hospital
  • Washington University Medical Center
  • University of Nebraska Medical Center
  • University Hospital-University of Oklahoma
  • Western Pennsylvania Hospital - Western Pennsylvania Cancer Center
  • Baylor University Medical Center
  • M.D. Anderson Cancer Center
  • South Texas Cancer Institute at Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

MEDI-507

MEDI-507

Outcomes

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.

Secondary Outcome Measures

Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics

Full Information

First Posted
December 10, 2008
Last Updated
December 10, 2008
Sponsor
MedImmune LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00806728
Brief Title
Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
November 1998 (Actual)
Study Completion Date
December 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Graft-Versus-Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MEDI-507
Arm Title
2
Arm Type
Experimental
Arm Description
MEDI-507
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MEDI-507
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics
Time Frame
Study Days 12 and 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Bruce McClain, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University Hospital-University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Western Pennsylvania Hospital - Western Pennsylvania Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Cancer Institute at Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs