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Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease

Phase 1
18 Years
Not Enrolling
Cancer, Graft-Versus-Host Disease

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Trial Information

Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease

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).

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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.

Outcome Time Frame:

Day 0-60

Safety Issue:


Principal Investigator

J. Bruce McClain, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC


United States: Food and Drug Administration

Study ID:




Start Date:

May 1998

Completion Date:

December 1998

Related Keywords:

  • Cancer
  • Graft-Versus-Host Disease
  • Graft vs Host Disease



University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Washington University Medical CenterSaint Louis, Missouri  63105
City of Hope National Medical CenterLos Angeles, California  91010
Baylor University Medical CenterDallas, Texas  75246
University of Colorado Health Sciences CenterDenver, Colorado  80262
M.D. Anderson Cancer CenterHouston, Texas  77030
University of Michigan HospitalAnn Arbor, Michigan  48109
University Hospital-University of OklahomaOklahoma City, Oklahoma  73104
Western Pennsylvania Hospital - Western Pennsylvania Cancer CenterPittsburgh, Pennsylvania  15224
South Texas Cancer Institute at Methodist HospitalSan Antonio, Texas  78229