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)

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00806208
First received: December 9, 2008
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
Graft-Versus-Host Disease
Drug: MEDI-507
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety; first infusion of study drug [ Time Frame: Through Study Day 44 ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: January 1999
Study Completion Date: March 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806208

Locations
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Texas
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
  More Information

No publications provided

Responsible Party: J. Bruce McClain, M.D., Medimmune Inc.
ClinicalTrials.gov Identifier: NCT00806208     History of Changes
Other Study ID Numbers: MI-CP046
Study First Received: December 9, 2008
Last Updated: December 10, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014