Study of MEDI 507 in the Treatment of Pediatric Patients

Graft Versus Host Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813618
• Other study ID #: MI-CP049
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: December 19, 2008
• Start date: September 1999
• Est. completion date: August 2004

Study information

• Verified date: December 2008
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• MEDI-507
0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9
• MEDI-507
0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
• MEDI-507
0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9

Locations

Country	Name	City	State
United States	Univ. of Michigan Medical Center	Ann Arbor	Michigan
United States	Children's Hospital	Birmingham	Alabama
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Hackensack U. Medical Center	Hackensack	New Jersey
United States	Children's Hospital of Orange County	Orange	California
United States	The Children's Hosp. of Phila., Abramson Ped. Research Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes