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Home > "H" Clinical Trials Conditions > Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease



Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

For Condition: Graft Versus Host Disease
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: OBJECTIVES: - Compare the efficacy of prednisone and cyclosporine with or without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease (GVHD). - Compare the event-free and overall survival in patients treated with these regimens. - Compare the health-related quality of life, including longitudinal change in and magnitude of persistent disability, in patients treated with these regimens. - Correlate cytokine levels and T-helper cell subtypes with chronic GVHD activity and response in patients treated with these regimens. - Correlate whole blood hydroxychloroquine levels with response and toxicity in patients treated with these regimens. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are randomized to one of two treatment arms. - Arm I: Patients receive standard therapy comprising prednisone orally or IV 2-3 times daily or every other day and cyclosporine orally or IV twice daily (patients already receiving tacrolimus continue to receive tacrolimus orally or IV twice daily instead of cyclosporine). Patients also receive oral hydroxychloroquine twice daily. - Arm II: Patients receive standard therapy as in arm I and oral placebo twice daily. In both arms, treatment continues for 9 months in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months of therapy are taken off study. Quality of life is assessed at baseline, 1 month, 9 months, and then at 1 year. Patients are followed every month for 3 months, at 9 months, and then at 1 year. PROJECTED ACCRUAL: A total of 232 patients (116 per treatment arm) will be accrued for this study within 3.6 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/29 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed* newly diagnosed extensive chronic graft-versus-host disease (GVHD) of at least 1 organ system (e.g., lip, skin, or liver), documented by 1 of the following: - Generalized skin involvement of at least 50% of body surface area - Localized skin involvement and/or liver dysfunction with at least 1 of the following: - Liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis - Eye involvement (Schirmer's test with less than 5 mm wetting) - Involvement of minor salivary glands or oral mucosa on lip biopsy - Involvement of any other target organs - Involvement of at least 2 target organs - Prior allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation from a family member or unrelated donor for malignancy - No recurrence of malignancy after transplantation NOTE: *Histologic confirmation may be "consistent with GVHD" or "diagnostic of GVHD" PATIENT CHARACTERISTICS: Age: - 1 to 29 Performance status: - Lansky 50-100% OR - Karnofsky 50-100% Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 Hepatic: - See Disease Characteristics Renal: - Creatinine less than 1.5 times upper limit of normal OR - Creatinine clearance at least 60 mL/min Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No lysosomal storage disorder - No uncontrolled infection (e.g., persistent bacterial, fungal, or viral infection despite appropriate antimicrobial therapy) - No G6PD deficiency - No history of psoriasis or porphyria - No hypersensitivity to 4-aminoquinolines - No prior retinal or visual field changes due to 4-aminoquinolines PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - Not specified Endocrine therapy: - Concurrent steroids for treatment and/or prophylaxis of acute GVHD allowed if prednisone dose is no greater than 1 mg/kg/day (or equivalent) - Concurrent topical steroids allowed Radiotherapy: - Not specified Surgery: - Not specified Other: - No prior treatment for chronic GVHD except the following: - Topical treatment - Adjustments of cyclosporine or tacrolimus doses - Up to 25% increase in steroid dose (only if done as a reversal of a recent taper) - Concurrent cyclosporine or tacrolimus allowed - No other concurrent systemic or topical immunosuppressants
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AndrewGilman,  Study Chair,  Children's Mercy Hospital

Deaconess Medical Center *Recruiting*
Spokane,  Washington,  99210-0248
United States
Recruiting Steven  Bergstrom 509-473-7012

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Donna  Reece 859-257-4500

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Peter  Anderson 507-284-2511

Children's Hospital of Michigan *Recruiting*
Detroit,  Michigan,  48201
United States
Recruiting Esteban  Abella 313-745-5515

Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack,  New Jersey,  07601
United States
Recruiting Joel  Brochstein 201-996-5600

New York Medical College *Recruiting*
Valhalla,  New York,  10595
United States
Recruiting M.  Ozkaynak 914-493-7997

Presbyterian-St Luke's Medical Center *Recruiting*
Denver,  Colorado,  80218
United States
Recruiting Edward  Arenson 303-839-6000

Washington University Medical Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Robert  Hayashi 314-454-4118

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0914
United States
Recruiting Raymond  Hutchinson 734-936-8785

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78207
United States
Recruiting Paul  Thomas 210-704-3405

Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford,  California,  94305-5208
United States
Recruiting Michael  Amylon 650-723-5535

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Robert  Fallon 317-274-8784

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting Michael  Lill 310-423-2997

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-3000
United States
Recruiting Joseph  Rosenthal 626-359-8111

Floating Hospital for Children *Recruiting*
Boston,  Massachusetts,  02111
United States
Recruiting Cynthia  Kretschmar 617-636-5535

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Mitchell  Cairo 212-305-8316

Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland,  Oregon,  97239-3098
United States
Recruiting H.  Nicholson 503-494-1543

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1009
United States
Recruiting Raymond  Tannous 319-356-1905

Medical College of Georgia Comprehensive Cancer Center *Recruiting*
Augusta,  Georgia,  30912-4000
United States
Recruiting Hernan  Sabio 706-721-3626

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390-9063
United States
Recruiting Victor  Aquino 214-648-3074

St. Jude Children's Research Hospital *Recruiting*
Memphis,  Tennessee,  38105-2794
United States
Recruiting Rupert  Handgretinger 901-495-4496

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Joan  Morris 501-320-1494

Kosair Children's Hospital *Recruiting*
Louisville,  Kentucky,  40232
United States
Recruiting Roger  Herzig 502-629-6000

Rainbow Babies and Children's Hospital *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Michael  Nieder 216-844-3345

Baylor College of Medicine *Recruiting*
Houston,  Texas,  77030-2399
United States
Recruiting Ingrid  Kuehnle 832-824-4758

CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay,  Wisconsin,  54301
United States
Recruiting Thomas  Saphner 920-432-5134

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Jacqueline  Kraveka 843-792-2957

Swiss Pediatric Oncology Group Bern *Recruiting*
Bern,  ,  CH 3010
Switzerland
Recruiting Kurt  Leibundgut 41-31-632-9337

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Ka  Chan 713-792-3326

All Children's Hospital *Recruiting*
St. Petersburg,  Florida,  33701
United States
Recruiting Hans-Christoph  Rossbach 813-892-4176

Sydney Children's Hospital *Recruiting*
Randwick,  New South Wales,  2031
Australia
Recruiting Marcus  Vowels 61-2-9382-1733

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting Katherine  Matthay 415-353-9510

Miami Children's Hospital *Recruiting*
Miami,  Florida,  33155-4069
United States
Recruiting John  Fort 305-662-8360

Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville,  Florida,  32610-0342
United States
Recruiting John  Graham-Pole 352-392-5633

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-6310
United States
Recruiting Haydar  Frangoul 615-936-1762

Children's Hospital and Research Center at Oakland *Recruiting*
Oakland,  California,  94609
United States
Recruiting Mark  Walters 510-428-3374

Pediatric Hematology and Oncology Associates of South Texas, PLLC *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Guy  Grayson 210-614-4011

Schneider Children's Hospital *Recruiting*
New Hyde Park,  New York,  11042
United States
Recruiting Arlene  Redner 718-470-3460

Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Michael  Graham 520-626-6044

Maine Children's Cancer Program *Recruiting*
Scarborough,  Maine,  04074-9308
United States
Recruiting Craig  Hurwitz 207-885-7565

Children's Hospital of Denver *Recruiting*
Denver,  Colorado,  80218-1088
United States
Recruiting Roger  Giller 303-861-6892

Children's Memorial Hospital - Chicago *Recruiting*
Chicago,  Illinois,  60614
United States
Recruiting Morris  Kletzel 773-880-3265

UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha,  Nebraska,  68198-3330
United States
Recruiting Alfred  Grovas 402-559-7257

Inova Fairfax Hospital *Recruiting*
Falls Church,  Virginia,  22042-3300
United States
Recruiting Eva  Wallace-Perdahl 703-698-1110

Methodist Cancer Center at Methodist Specialty and Transplant Hospital *Recruiting*
St. Louis,  Missouri,  63104
United States
Recruiting Dennis  O'Connor 314-577-5638

Starship Children's Hospital *Recruiting*
Auckland,  , 
New Zealand
Recruiting Lochie  Teague 64-9-307-4949 ext. 6295

Medical College of Georgia *Recruiting*
Augusta,  Georgia,  30912-3730
United States
Recruiting Shafqat  Shah 706-721-3626

Children's Hospitals and Clinics - Minneapolis *Recruiting*
Minneapolis,  Minnesota,  55404
United States
Recruiting Maura  O'Leary 612-813-5940

Children's National Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20010-2970
United States
Recruiting Naynesh  Kamani 202-884-2800

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97239-3098
United States
Recruiting F.  Johnson 503-494-1617

Children's Hospital and Health Center, San Diego *Recruiting*
San Diego,  California,  92123-4282
United States
Recruiting Richard  Kadota 858-966-5811

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Farid  Boulad 212-639-6684

San Jorge Childrens Hospital *Recruiting*
Santurce,  ,  00912
Puerto Rico
Recruiting Luis  Clavell 787-728-1575

Spectrum Health and DeVos Children's Hospital *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Daniel  Pietryga 616-391-9127

CancerCare Manitoba *Recruiting*
Winnipeg,  Manitoba,  R3E 0V9
Canada
Recruiting Marlis  Schroeder 204-787-7095

Nemours Children's Clinic *Recruiting*
Jacksonville,  Florida,  32207-8482
United States
Recruiting Michael  Joyce 904-390-3793

Children's Hospital at Westmead *Recruiting*
Westmead,  New South Wales,  2145
Australia
Recruiting Peter  Shaw 612-984-50000

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Michael  Nieder 216-844-3345

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Joanne  Kurtzberg 919-668-1100

Royal Children's Hospital *Recruiting*
Parkville,  Victoria,  3052
Australia
Recruiting Karin  Tiedemann 61-3-345-6750

Alberta Children's Hospital *Recruiting*
Calgary,  Alberta,  T2T 5C7
Canada
Recruiting Douglas  Strother 403-943-7272

Cancer Research Center of Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Randal  Wada 808-586-2963

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting Stephen  Lauer 404-315-2170

Massachusetts General Hospital Cancer Center *Recruiting*
Boston,  Massachusetts,  02114
United States
Recruiting Howard  Weinstein 617-724-3315

Midwest Children's Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting James  Casper 414-456-4153

University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Peter  Sadowitz 315-464-5294

McGill University *Recruiting*
Montreal,  Quebec,  H3H 1P3
Canada
Recruiting David  Mitchell 514-412-4445

Southern California Permanente Medical Group *Recruiting*
Downey,  California,  90242
United States
Recruiting Willye  Powell 562-803-2472

Hospital for Sick Children *Recruiting*
Toronto,  Ontario,  M5G 1X8
Canada
Recruiting John  Doyle 416-813-6200

Children's Mercy Hospital *Recruiting*
Kansas City,  Missouri,  64108
United States
Recruiting Andrew  Gilman 816-234-3265

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting John  Horan 585-275-1941

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431-5000
United States
Recruiting Kelly  Faucette 253-968-1864

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore,  Maryland,  21287
United States
Recruiting Allen  Chen 410-614-5055

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1781
United States
Recruiting Theodore  Moore 310-825-6708

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792-4108
United States
Recruiting Kenneth  DeSantes 608-263-8563

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Herbert  Cooper 919-966-3036

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Norma  Ramsay 612-273-2800

Kaiser Permanente Medical Center - Los Angeles *Recruiting*
Los Angeles,  California,  90027
United States
Recruiting Peter  Falk 323-783-5414

Princess Margaret Hospital for Children *Recruiting*
Perth,  Western Australia,  6001
Australia
Recruiting David  Baker 61-8-9340-8234

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City,  New York,  10016
United States
Recruiting Sharon  Gardner 212-263-8520

Cook Children's Medical Center - Fort Worth *Recruiting*
Ft. Worth,  Texas,  76104
United States
Recruiting Gretchen  Eames 682-885-2580

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Saul  Yanovich 202-444-7253

Cardinal Glennon Children's Hospital *Recruiting*
St. Louis,  Missouri,  63104
United States
Recruiting Dennis  O'Connor 314-577-5638

Medical Center of Princeton *Recruiting*
Los Angeles,  California,  90027-0700
United States
Recruiting Paul  Gaynon 323-669-2163

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Leslie  Lehmann 617-632-4932

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112
United States
Recruiting Carol  Bruggers 801-585-0303

Children's Hospital of Orange County *Recruiting*
Orange,  California,  92868
United States
Recruiting Steven  Neudorf 714-532-8636

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting Gail  Megason 601-984-5220

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting Stephen  Lauer 404-315-2170

Swiss Pediatric Oncology Group Lausanne *Recruiting*
Lausanne,  ,  CH 1011
Switzerland
Recruiting Maja  Popovic 41-21-314-3567

Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati,  Ohio,  45229-3039
United States
Recruiting Thomas  Gross 513-636-2469

Children's Hospital Los Angeles *Recruiting*
Los Angeles,  California,  90027-0700
United States
Recruiting Anna  Butturini 323-669-5687

Children's Hospital of Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19104
United States
Recruiting Nancy  Bunin 215-590-2255

Children's Hospital of Columbus *Recruiting*
Columbus,  Ohio,  43205-2696
United States
Recruiting Amanda  Termuhlen 614-722-3552

Women's and Children's Hospital *Recruiting*
North Adelaide,  South Australia,  5006
Australia
Recruiting Maria  Kirby 61-8-8161-7411

Royal Children's Hospital *Recruiting*
Brisbane,  Queensland,  4029
Australia
Recruiting Liane  Lockwood 617-363-61356

Hopital Sainte Justine *Recruiting*
Montreal,  Quebec,  H3T 1C5
Canada
Recruiting Martin  Champagne 514-345-4969

Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15213
United States
Recruiting Rakesh  Goyal 412-692-5055

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting Kenneth  Lucas 717-531-6012

Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting Saul  Yanovich 804-828-4360

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60601
United States
Recruiting James  Nachman 773-702-6808

British Columbia Children's Hospital *Recruiting*
Vancouver,  British Columbia,  V6H 3V4
Canada
Recruiting Jeffrey  Davis 604-875-2316

Children's Hospital of New Orleans *Recruiting*
New Orleans,  Louisiana,  70118
United States
Recruiting Rajasekharan  Warrier 504-568-4561

Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98105
United States
Recruiting Douglas  Hawkins 206-987-3096

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73190
United States
Recruiting George  Selby 405-271-4022

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048


Additional Information:
Study ID Numbers:
  CDR0000069231;  CCG-S9701,NCI-P02-0213,COG-ASCT0031
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031824

Other Graft Versus Host Disease Studies:
1. Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

2. Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract

3. Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment

4. Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

5. Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy

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Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

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