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

You may be eligible if

• 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:
• * Skin changes
• * Oral changes
• * Hepatic involvement
• * Gastrointestinal involvement
• * Sicca syndrome
• * Pulmonary involvement
• * Myofascial
• * Skeletal
• * Other inflammatory conditions (e.g., myositis, arthritis, polyserositis, or unexplained pericardial, pleural, or peritoneal effusions)
• * Autoantibodies
• * Extent of disease, defined according to the following classification:
• * Limited chronic GVHD, defined by 1 of the following:
• * Localized skin involvement and/or liver dysfunction
• * Involvement of only 1 target organ
• * Extensive chronic GVHD, defined by 1 of the following:
• * Generalized skin involvement of ≥ 50% of body surface area
• * Localized skin involvement and/or liver dysfunction AND ≥ 1 of the following:
• * Liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis
• * Eye involvement (Schirmer's test with \< 5 mm wetting)
• * Involvement of minor salivary glands or oral mucosa on lip biopsy
• * Involvement of any other target organs
• * Involvement of ≥ 2 target organs
• * Timing of onset, including onset of any of the following types:
• * Progressive onset defined as, evolving directly from acute GVHD, commonly with the development of typical manifestations such as oral or skin lichenoid changes or sclerodermatous skin changes
• * Quiescent onset, defined as developing after the resolution of acute GVHD
• * De novo onset, defined as developing with no prior history of acute GVHD
• 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)
• * Symptoms of acute GVHD allowed at the time of diagnosis of chronic GVHD
• Prior allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation from a family member or unrelated donor for malignancy required NOTE: \*Histologic confirmation may be "consistent with 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 ≥ 1,000/mm\^3, unless due to chronic GVHD (i.e., autoimmune neutropenia or bone marrow suppression)
• Hepatic:
• See Disease Characteristics
• Renal:
• Creatinine \< 1.5 times upper limit of normal OR
• Creatinine clearance ≥ 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
• No concurrent daclizumab or infliximab
• No concurrent thalidomide
• Chemotherapy:
• Not specified
• Endocrine therapy:
• Prior topical steroids for treatment of extensive chronic GVHD allowed
• Prior adjustment to prednisone dose allowed if done as a reversal of a taper
• Prior steroids (prednisone ≤ 1 mg/kg/day (or equivalent) for symptom management for up to 1 week before study entry allowed
• Concurrent steroids for treatment and/or prophylaxis of acute GVHD allowed if prednisone dose is ≤ 2 mg/kg/day (or equivalent)
• Concurrent topical steroids allowed
• Radiotherapy:
• Not specified
• Surgery:
• Not specified
• Other:
• No prior treatment for extensive chronic GVHD except the following:
• * Topical treatment (e.g., tacrolimus ointment or pimecrolimus cream)
• * Adjustments of cyclosporine or tacrolimus doses for GVHD prophylaxis or treatment of acute GVHD
• Concurrent cyclosporine or tacrolimus allowed
• * Cyclosporine must have been started before study entry
• No other concurrent systemic or topical immunosuppressants, including any of the following:
• * Azathioprine
• * Mycophenolate mofetil
• * Psoralen-ultraviolet light therapy
• * Photopheresis
• No administration of any of the following for 1 hour before until 2 hours after study drug administration:
• * Antacids
• * Sucralfate
• * Cholestyramine
• * Bicarbonate