Study of MEDI 507 in the Treatment of Pediatric Patients - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00813618

Purpose

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.

Condition	Intervention	Phase
Graft Versus Host Disease	Drug: MEDI-507	Phase I

Drug Information available for: Siplizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Safety assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD). [ Time Frame: Through Study Day 44 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the serum concentrations and pharmacokinetics (PK) of MEDI 507 and pharmacodynamic effects of MEDI-507 on the absolute lymphocyte count and dynamics of lymphocyte phenotypes. [ Time Frame: Through Study Day 364 ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	September 1999
Study Completion Date:	August 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MEDI-507	Drug: MEDI-507 0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9
2: Experimental MEDI-507	Drug: MEDI-507 0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
3: Experimental MEDI-507	Drug: MEDI-507 0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9

Detailed Description:

This is a Phase I, open-label dose escalation trial of MEDI-507 in pediatric SCT and BMT recipients with at least Grade II acute GvHD. All patients will receive steroid therapy and MEDI-507 for treatment of GvHD

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813618

Locations

United States, Alabama
Children's Hospital
Birmingham, Alabama, United States, 35233
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 606014
United States, Michigan
Univ. of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hackensack U. Medical Center
Hackensack, New Jersey, United States, 07601
United States, Pennsylvania
The Children's Hosp. of Phila., Abramson Ped. Research Center
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

MedImmune LLC

More Information

Responsible Party:	Medimmune LLC ( Christine A. Dingivan, MD )
Study ID Numbers:	MI-CP049
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00813618
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Acute GvHD of at least Grade II severity

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009