Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease

NCT00806728 | Completed Phase 1

• 1 other identifier: MI-CP042
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 10

Brief Summary

A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.

Conditions

Cancer; Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.

  Day 0-60

Secondary Outcomes (1)

• Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics

  Study Days 12 and 44

Study Arms (2)

1

EXPERIMENTAL

MEDI-507

Drug: MEDI-507

2

EXPERIMENTAL

MEDI-507

Drug: MEDI-507

Interventions

MEDI-507 DRUG

0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Allogeneic bone marrow or hematopoietic stem cell graft recipients
• Acute GVHD of at least grade II severity
• Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
• Evidence of engraftment (ANC over 1000 cells/mm3)
• Histologic evidence of GVHD from biopsy performed during the current episode
• Received GVHD prophylaxis of methotrexate, tacrolimus or cyclosporine
• Age at least 18 years
• Body weight under 130 kg
• Both males and females are eligible but females of childbearing potential will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)

You may not qualify if:

• Previous receipt of MEDI-507
• Clinical or histologic manifestation of chronic GVHD
• Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
• Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
• More than one allogeneic bone marrow or hematopoietic stem cell allograft
• Moribund and unlikely (in the opinion of the investigator) to survive 15 days
• 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)
• Any of the following clinical settings or diagnoses:
• Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
• Histologically confirmed veno-occlusive disease of the liver
• Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (10)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University Hospital-University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Western Pennsylvania Hospital - Western Pennsylvania Cancer Center

Pittsburgh, Pennsylvania, 15224, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Cancer Institute at Methodist Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms; Graft vs Host Disease

Interventions

siplizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• J. Bruce McClain, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: May 1, 1998
• Primary Completion: November 1, 1998
• Study Completion: December 1, 1998
• Last Updated: December 11, 2008

Record last verified: 2008-12

Locations

US (10)