Pediatric GvHD: Study of MEDI 507 in the Treatment of Pediatric Patients

Sponsor

MedImmune LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00813618

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.7

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease	Drug: MEDI-507 Drug: MEDI-507 Drug: MEDI-507	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

MEDI-507

Drug: MEDI-507

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

Experimental: 2

MEDI-507

Drug: MEDI-507

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

Experimental: 3

MEDI-507

Drug: MEDI-507

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

Outcome Measures

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). [Through Study Day 44]

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. [Through Study Day 364]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital	Birmingham	Alabama	United States	35233
2	Children's Hospital of Orange County	Orange	California	United States	92868
3	Children's Memorial Hospital	Chicago	Illinois	United States	606014
4	Univ. of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
5	Hackensack U. Medical Center	Hackensack	New Jersey	United States	07601
6	The Children's Hosp. of Phila., Abramson Ped. Research Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00813618

Other Study ID Numbers:

MI-CP049

First Posted:

Dec 23, 2008

Last Update Posted:

Dec 23, 2008

Last Verified:

Dec 1, 2008

Keywords provided by , ,

Acute GvHD of at least Grade II severity

Additional relevant MeSH terms:

Graft vs Host Disease

Study Results

No Results Posted as of Dec 23, 2008