Clinical trial NCT00806728: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Graft-Versus-Host Disease
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
timeFrame: Day 0-60
Secondary outcomes:
measure: Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics
timeFrame: Study Days 12 and 44
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Oklahoma City
country: United States
facility: University Hospital-University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital - Western Pennsylvania Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Cancer Institute at Methodist Hospital
state: Texas
Study officials:
affiliation: MedImmune LLC
name: J. Bruce McClain, M.D.
role: STUDY_DIRECTOR
References: