Trial record 1 of 1576 for:    Farber's Disease
Previous Study | Return to List | Next Study

Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053976
First received: February 5, 2003
Last updated: February 6, 2009
Last verified: December 2003
  Purpose

RATIONALE: Daclizumab combined with methylprednisolone may be an effective treatment for acute graft-versus-host disease caused by bone marrow transplantation. It is not yet known if methylprednisolone is more effective with or without daclizumab in treating acute graft-versus-host disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without daclizumab in treating patients who have acute graft-versus-host disease following donor bone marrow transplantation.


Condition Intervention Phase
Graft Versus Host Disease
Biological: daclizumab
Drug: methylprednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2002
Detailed Description:

OBJECTIVES:

  • Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
  • Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
  • Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
  • Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100.
  • Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.

Patients are followed at 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 166-190 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Acute graft-versus-host disease (GVHD) requiring systemic therapy

    • Grade 2 (skin GVHD)
    • Grade 2-4 (overall GVHD)
  • Received allogeneic bone marrow transplantation
  • No acute GVHD diagnosed solely by upper gastrointestinal involvement
  • No GVHD from donor lymphocyte infusion

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No mental or emotional conditions that would preclude study therapy
  • No known hypersensitivity to daclizumab

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior daclizumab

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 7 days since prior prophylactic or therapeutic steroids at greater than 1 mg/kg/day
  • Steroids for amphotericin premedication allowed provided dose is less than 1 mg/kg/day

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational therapies
  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: NCT00053976

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2698
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Stephanie J. Lee, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00053976     History of Changes
Other Study ID Numbers: CDR0000269672, DFCI-99279, RPCI-DS-0218, ROCHE-RPCI-DS-0218
Study First Received: February 5, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
graft versus host disease

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

ClinicalTrials.gov processed this record on August 27, 2014