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

Inclusion Criteria

• •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