Trial record 1 of 1417 for:
Farber's Disease
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
Recruitment status was Active, not recruiting
Sponsor:
Dana-Farber Cancer Institute
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
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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:
MedlinePlus related topics:
Cancer
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Daclizumab
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | October 2002 |
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
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 Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013