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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031824 |
Purpose
RATIONALE: Hydroxychloroquine may decrease the immune response and be effective in treating chronic graft-versus-host disease. It is not yet known if standard therapy for graft-versus-host disease is more effective with or without hydroxychloroquine.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy alone with that of standard therapy plus hydroxychloroquine in treating patients who have newly diagnosed chronic graft-versus-host disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease |
Drug: cyclosporine Drug: hydroxychloroquine Drug: prednisone Drug: tacrolimus |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease |
| Study Start Date: | April 2002 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are randomized to one of two treatment arms.
Patients may receive standard therapy comprising prednisone orally or IV 2-3 times daily or every other day and cyclosporine orally or IV twice daily or tacrolimus orally twice daily or IV by continuous infusion before randomization. Patients not receiving cyclosporine or tacrolimus prior to randomization may receive cyclosporine or tacrolimus after randomization according to institutional preference.
In both arms, treatment continues for 9 months in the absence of disease progression or unacceptable toxicity. Patients with no response after 2 months of therapy are taken off study.
Quality of life is assessed at baseline, 1 month, 9 months, and 1 year.
Patients are followed every month for 3 months and at 9 months.
PROJECTED ACCRUAL: A total of 232 patients (116 per treatment arm) will be accrued for this study within 3.6 years.
Eligibility| Ages Eligible for Study: | 1 Year to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* newly diagnosed extensive chronic graft-versus-host disease (GVHD) of ≥ 1 organ system (e.g., lip, skin, or liver) documented by all of the following:
Clinicopathologic features of GVHD, including involvement of any of the following organ systems:
Extent of disease, defined according to the following classification:
Limited chronic GVHD, defined by 1 of the following:
Extensive chronic GVHD, defined by 1 of the following:
Localized skin involvement and/or liver dysfunction AND ≥ 1 of the following:
Timing of onset, including onset of any of the following types:
Must have ≥ 1 typical clinical manifestation of chronic GVHD that differs from that of acute GVHD (e.g., rash, anorexia, nausea, emesis, diarrhea, abdominal pain, or cholestasis)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No prior treatment for extensive chronic GVHD except the following:
Concurrent cyclosporine or tacrolimus allowed
No other concurrent systemic or topical immunosuppressants, including any of the following:
No administration of any of the following for 1 hour before until 2 hours after study drug administration:
Contacts and Locations
Show 104 Study Locations| Study Chair: | Andrew L. Gilman, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00031824 History of Changes |
| Other Study ID Numbers: | CDR0000069231, COG-ASCT0031, CCG-S9701, NCI-P02-0213 |
| Study First Received: | March 8, 2002 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Federal Government |
|
graft versus host disease |
|
Graft vs Host Disease Immune System Diseases Cyclosporins Cyclosporine Hydroxychloroquine Tacrolimus Prednisone Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Anti-Inflammatory Agents |