Study of MEDI 507 in the Treatment of Pediatric Patients (Pediatric GvHD)

Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)

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.

Study Overview

• Status: Completed
• Conditions: Graft Versus Host Disease
• Intervention / Treatment: Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; MEDI-507	Drug: MEDI-507; 0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9; Drug: MEDI-507; 0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9; Drug: MEDI-507; 0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
EXPERIMENTAL: 2; MEDI-507	Drug: MEDI-507; 0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9; Drug: MEDI-507; 0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9; Drug: MEDI-507; 0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
EXPERIMENTAL: 3; MEDI-507	Drug: MEDI-507; 0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9; Drug: MEDI-507; 0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9; Drug: MEDI-507; 0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	Through Study Day 44

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Through Study Day 364

Collaborators and Investigators

• Sponsor: MedImmune LLC

Study record dates

Study Major Dates

• Study Start: September 1, 1999
• Primary Completion (ACTUAL): June 1, 2004
• Study Completion (ACTUAL): August 1, 2004

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (ESTIMATE): December 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 23, 2008
• Last Update Submitted That Met QC Criteria: December 19, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Acute GvHD of at least Grade II severity
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: MI-CP049