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

Cancer Clinical Trial

Official title:

Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806728
• Other study ID #: MI-CP042
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2008
• Last updated: December 10, 2008
• Start date: May 1998
• Est. completion date: December 1998

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

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.

Description:

To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 1998
• Est. primary completion date: November 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	City of Hope National Medical Center	Duarte	California
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	University Hospital-University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Western Pennsylvania Hospital - Western Pennsylvania Cancer Center	Pittsburgh	Pennsylvania
United States	South Texas Cancer Institute at Methodist Hospital	San Antonio	Texas
United States	Washington University Medical Center	St. Louis	Missouri

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 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	Yes
Secondary	Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics		Study Days 12 and 44	Yes