Study of MEDI 507 in the Treatment of Pediatric Patients
NCT ID: NCT00813618
Last Updated: 2008-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
1999-09-30
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
MEDI-507
MEDI-507
0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9
2
MEDI-507
MEDI-507
0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
3
MEDI-507
MEDI-507
0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
Interventions
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MEDI-507
0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9
MEDI-507
0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
MEDI-507
0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Medimmune LLC
Locations
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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
Countries
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Other Identifiers
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MI-CP049
Identifier Type: -
Identifier Source: org_study_id