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

Sponsor
MedImmune LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00806728
Collaborator
(none)
17
Enrollment
10
Locations
2
Arms
7
Duration (Months)
1.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
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 1, 1998
Actual Primary Completion Date :
Nov 1, 1998
Actual Study Completion Date :
Dec 1, 1998

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

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. [Day 0-60]

Secondary Outcome Measures

  1. Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics [Study Days 12 and 44]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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)

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 University of Nebraska Medical Center Omaha Nebraska United States 68198
6 University Hospital-University of Oklahoma Oklahoma City Oklahoma United States 73104
7 Western Pennsylvania Hospital - Western Pennsylvania Cancer Center Pittsburgh Pennsylvania United States 15224
8 Baylor University Medical Center Dallas Texas United States 75246
9 M.D. Anderson Cancer Center Houston Texas United States 77030
10 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00806728
Other Study ID Numbers:
  • MI-CP042
First Posted:
Dec 11, 2008
Last Update Posted:
Dec 11, 2008
Last Verified:
Dec 1, 2008
Additional relevant MeSH terms:
Graft vs Host Disease

Study Results

No Results Posted as of Dec 11, 2008