Study of MEDI 507 in the Treatment of Pediatric Patients

NCT00813618 | Completed Phase 1

• 1 other identifier: MI-CP049
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

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.

Conditions

Graft Versus Host Disease

Keywords

Acute GvHD of at least Grade II severity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

EXPERIMENTAL

MEDI-507

Drug: MEDI-507

2

EXPERIMENTAL

MEDI-507

Drug: MEDI-507

3

EXPERIMENTAL

MEDI-507

Drug: MEDI-507

Interventions

MEDI-507 DRUG

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

1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (6)

Children's Hospital

Birmingham, Alabama, 35233, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 606014, United States

Location

Univ. of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Hackensack U. Medical Center

Hackensack, New Jersey, 07601, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

siplizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 23, 2008
• Study Start: September 1, 1999
• Primary Completion: June 1, 2004
• Study Completion: August 1, 2004
• Last Updated: December 23, 2008

Record last verified: 2008-12

Locations

US (6)