Study of MEDI 507 in the Treatment of Pediatric Patients

Completed · Phase 1

Conditions studied: Graft Versus Host Disease

In brief

To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD.

Key facts

Study ID

NCT00813618

Run by

MedImmune LLC

People needed

10

Starts

1999-09-01

Expected to finish

2004-08-01

Last updated by the study team

2008-12-23

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Allogeneic BMT or SCT recipients
• Acute GvHD of at least Grade II severity
• Age 2 to 17 years
• Evidence of engraftment (ANC over 500 cells/mm3 on two consecutive days within seven days before study entry)
• Receipt of GvHD prophylaxis regimen including methotrexate, tacrolimus or cyclosporine
• Receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) between eight and 24 hours prior to the first MEDI-507 dose for GvHD treatment
• Both males and females are eligible, but sexually active females at risk of pregnancy of childbearing potential must agree to use an effective method of avoiding pregnancy (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) beginning 30 days before the first study infusion and continuing through 60 days after the final study infusion.

You may not qualify if…

• Treatment of acute GvHD with methylprednisolone (or equivalent corticosteroid) at a total dose exceeding 14 mg/kg (or equivalent) over a seven day period (for example, 2 mg/kg/day for seven days)
• Previous receipt of MEDI 507
• Previous treatment with any anti-T cell monoclonal antibodies, such as OKT3, daclizumab (Zenapax), or basiliximab (Simulect)
• Treatment with anti-thymocyte globulin (ATG, ATGAM or others) within 14 days
• More than one allogeneic bone marrow or hematopoietic stem cell allograft
• 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) or current participation in a research protocol in which an investigational agent was administered
• Any of the following clinical settings or diagnoses:
• documented or presumed significant active infection
• pregnancy or nursing mother
• evidence of infection with HIV-1, hepatitis B or C virus
• hemodialysis or chronic peritoneal dialysis
• use of a ventilator
• chronic GvHD
• active veno-occlusive disease of the liver
• moribund patient

Where it is running

• Children's Hospital — Birmingham, Alabama, United States
• Children's Hospital of Orange County — Orange, California, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Univ. of Michigan Medical Center — Ann Arbor, Michigan, United States
• Hackensack U. Medical Center — Hackensack, New Jersey, United States
• The Children's Hosp. of Phila., Abramson Ped. Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.