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)

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00806208
• Collaborator: (none)
• Enrollment: 34
• Locations: 3
• Arms: 5
• Duration (Months): 14
• Patients Per Site: 11.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Graft-Versus-Host Disease	Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507; Drug: MEDI-507; Other: Placebo	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jan 1, 1999
• Actual Primary Completion Date: Jan 1, 2000
• Actual Study Completion Date: Mar 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 MEDI 507 and Methylprednisolone	Drug: MEDI-507; 0.012 mg/kg MEDI 507 and Methylprednisolone
Active Comparator: 2 MEDI-507 and Methylprednisolone	Drug: MEDI-507; 0.04 mg/kg MEDI 507 and Methylprednisolone
Active Comparator: 3 MEDI-507 and Methylprednisolone	Drug: MEDI-507; 0.12 mg/kg MEDI 507 and Methylprednisolone
Active Comparator: 4 MEDI-507 and Methylprednisolone	Drug: MEDI-507; 0.4 mg/kg MEDI 507 and Methylprednisolone
Placebo Comparator: 5 Placebo	Other: Placebo; Placebo IV (alternative) study days 0, 3,6, and 9

Outcome Measures

Primary Outcome Measures

1. Safety; first infusion of study drug [Through Study Day 44]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University Medical Center	St. Louis	Missouri	United States	63110
2	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
3	Baylor Institute of Transplant Sciences	Dallas	Texas	United States	75246

Sponsors and Collaborators

• MedImmune LLC

Investigators

• Study Director: J. Bruce McClain, M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00806208
• Other Study ID Numbers: MI-CP046
• First Posted: Dec 10, 2008
• Last Update Posted: Dec 11, 2008
• Last Verified: Dec 1, 2008

• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Dec 11, 2008