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

This study has been completed.

Sponsor:

Information provided by:

MedImmune LLC

ClinicalTrials.gov Identifier:

NCT00813618

First received: December 19, 2008

Last updated: NA

Last verified: December 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 19, 2008
Last Updated Date	December 19, 2008
Start Date ^ICMJE	September 1999
Primary Completion Date	June 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2008)	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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 19, 2008)	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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of MEDI 507 in the Treatment of Pediatric Patients
Official Title ^ICMJE	Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Graft Versus Host Disease
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 MEDI-507 Intervention: Drug: MEDI-507 Experimental: 2 MEDI-507 Intervention: Drug: MEDI-507 Experimental: 3 MEDI-507 Intervention: Drug: MEDI-507
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	10
Completion Date	August 2004
Primary Completion Date	June 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	2 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00813618
Other Study ID Numbers ^ICMJE	MI-CP049
Has Data Monitoring Committee	No
Responsible Party	Christine A. Dingivan, MD, Medimmune LLC
Study Sponsor ^ICMJE	MedImmune LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MedImmune LLC
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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