|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease |
| Study Start Date: | April 2002 |
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
Hide Study Locations| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Children's Hospital and Health Center, San Diego | |
| San Diego, California, United States, 92123-4282 | |
| Children's Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94143 | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Kaiser Permanente Medical Center - Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | |
| Palo Alto, California, United States, 94304-1812 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| University Medical Center at Princeton | |
| Los Angeles, California, United States, 90027-0700 | |
| United States, Colorado | |
| Children's Hospital Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| Presbyterian - St. Luke's Medical Center | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| Lombardi Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155-4069 | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207-8482 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | |
| Atlanta, Georgia, United States, 30322 | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912-4000 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60601 | |
| United States, Indiana | |
| Riley Children Cancer Center at Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202-5225 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | |
| New Orleans, Louisiana, United States, 70118 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Children's Cancer Program | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Floating Hospital for Children | |
| Boston, Massachusetts, United States, 02111 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114-2696 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| DeVos Children's Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0914 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics - Minneapolis/St. Paul | |
| Minneapolis, Minnesota, United States, 55404 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Methodist Cancer Center at Methodist Specialty and Transplant Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| St. Louis Children's Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, New Jersey | |
| Cancer Center at Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11042 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7070 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Columbus Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73190 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Doernbecher Children's Hospital at Oregon Health & Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Children's Hospital at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt Children's Hospital | |
| Nashville, Tennessee, United States, 37232-6310 | |
| United States, Texas | |
| Pediatric Hematology and Oncology Associates of South Texas, PLLC | |
| San Antonio, Texas, United States, 78229 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| MBCCOP - South Texas Pediatrics | |
| San Antonio, Texas, United States, 78229-3900 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030-2399 | |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390-9063 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| INOVA Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431-0001 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-4108 | |
| Australia, New South Wales | |
| Children's Hospital at Westmead | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Royal Children's Hospital | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T2T 5C7 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| New Zealand | |
| Starship Children's Health | |
| Auckland, New Zealand | |
| Puerto Rico | |
| San Jorge Children's Hospital | |
| Santurce, Puerto Rico, 00912 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, CH 3010 | |
| Swiss Pediatric Oncology Group Lausanne | |
| Lausanne, Switzerland, CH 1011 | |
| Study Chair: | Andrew L. Gilman, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069231, COG-ASCT0031, CCG-S9701, NCI-P02-0213 |
| Study First Received: | March 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00031824 History of Changes |
| Health Authority: | United States: Federal Government |
|
graft versus host disease |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Antiprotozoal Agents Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Tacrolimus Cyclosporins Hormones Antimalarials |
Antiparasitic Agents Antifungal Agents Therapeutic Uses Dermatologic Agents Immune System Diseases Antineoplastic Agents, Hormonal Enzyme Inhibitors Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Hydroxychloroquine Graft vs Host Disease Antirheumatic Agents |