Back to results

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

Primary Purpose

Graft Versus Host Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MEDI-507

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring Acute GvHD of at least Grade II severity

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital
Children's Hospital of Orange County
Children's Memorial Hospital
Univ. of Michigan Medical Center
Hackensack U. Medical Center
The Children's Hosp. of Phila., Abramson Ped. Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

MEDI-507

Outcomes

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).

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.

Full Information

NCT ID

NCT00813618

First Posted

December 19, 2008

Last Updated

December 19, 2008

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT00813618

Brief Title

Study of MEDI 507 in the Treatment of Pediatric Patients

Acronym

Pediatric GvHD

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

September 1999 (undefined)

Primary Completion Date

June 2004 (Actual)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

MedImmune LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft Versus Host Disease

Keywords

Acute GvHD of at least Grade II severity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

MEDI-507

Arm Title

Arm Type

Experimental

Arm Description

MEDI-507

Arm Title

Arm Type

Experimental

Arm Description

MEDI-507

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9

Intervention Type

Drug

Intervention Name(s)

MEDI-507

Intervention Description

0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Children's Hospital

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Children's Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Children's Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

606014

Country

United States

Facility Name

Univ. of Michigan Medical Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Hackensack U. Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

The Children's Hosp. of Phila., Abramson Ped. Research Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of MEDI 507 in the Treatment of Pediatric Patients

We'll reach out to this number within 24 hrs