Trial for Evaluation of Safety of Escalating Dose Levels of MEDI-507 in Patients for Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)

Graft-Versus-Host Disease Clinical Trial

Official title:

Phase I Evaluation of Safety, Pharmacokinetics and Activity of Escalating Dose Levels of MEDI 507 in Patients Receiving Methylprednisolone for Initial Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806208
• Other study ID #: MI-CP046
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2008
• Last updated: December 10, 2008
• Start date: January 1999
• Est. completion date: March 2000

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 trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.

Description:

The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2000
• Est. primary completion date: January 2000
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. allogeneic bone marrow or hematopoietic stem cell graft recipients

2. acute GvHD of at least Grade II severity

3. receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug

4. evidence of engraftment (ANC over 1,000 cells/mm3)

5. histologic evidence of GvHD from biopsy performed during the current episode

6. receipt of GvHD prophylaxis of methotrexate, tacrolimus or cyclosporine

7. age at least 18 years

8. body weight under 130 kg

9. Both males and females are eligible, but females of childbearing potential, unless previously surgically sterilized, agree to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant7 or DepoProvera7) beginning with the first study injection and continuing through 60 days after the final study injection.

Exclusion Criteria:

1. previous receipt of MEDI 507

2. diagnosis of chronic GvHD

3. previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)

4. receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days

5. treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD

6. intolerance or history of intolerance to corticosteroids such that it is unlikely the patient will be able to complete at least ten days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or equivalent)

7. more than one allogeneic bone marrow or hematopoietic stem cell allograft

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• MEDI-507
0.012 mg/kg MEDI 507 and Methylprednisolone
• MEDI-507
0.04 mg/kg MEDI 507 and Methylprednisolone
• MEDI-507
0.12 mg/kg MEDI 507 and Methylprednisolone
• MEDI-507
0.4 mg/kg MEDI 507 and Methylprednisolone

Other:
• Placebo
Placebo IV (alternative) study days 0, 3,6, and 9

Locations

Country	Name	City	State
United States	Baylor Institute of Transplant Sciences	Dallas	Texas
United States	University of Nebraska Medical Center	Omaha	Nebraska
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; first infusion of study drug		Through Study Day 44	Yes