Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant

DISEASE CHARACTERISTICS:

• Newly diagnosed acute graft-versus-host disease (GVHD)
• Has undergone nonmyeloablative allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-matched related or unrelated donor ≥ 14 days ago

• Treatment of GVHD with glucocorticoids indicated by 1 of the following criteria:

  • Initial treatment with prednisone or methylprednisolone at 2 mg/kg indicated (in the judgement of attending physician) by any of the following:

    • Severity of GVHD requires hospitalization
    • GVHD manifestations include symptoms other than anorexia, nausea, and vomiting
    • GVHD begins within 2-3 weeks after HSCT
    • GVHD manifestations progress rapidly from 1 day to the next before treatment
  • Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of attending physician)

• No pleural effusion or ascites (i.e., free-flowing fluid by lateral decubitus views)

  • Mere blunting of costo-phrenic angles on a posterior anterior chest x-ray is not sufficient
• No GVHD after donor lymphocyte infusion
• No hallmarks of chronic GVHD
• No bronchiolitis obliterans

PATIENT CHARACTERISTICS:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study treatment
• No severe mucositis (grade 3 or 4) indicated by erythema, edema, or ulcerations requiring hydration, parenteral nutritional support, or intubation or resulting in aspiration pneumonia
• Absolute neutrophil count ≥ 1,500/mm^3
• Bilirubin ≤ 2 times upper limit of normal (ULN) (unless abnormality attributable to GVHD)
• AST and ALT ≤ 2 times ULN (unless abnormality attributable to GVHD)
• Creatinine clearance ≥ 50 mL/min

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior prednisone or methylprednisolone at 2 mg/kg for > 72 hours or at 1 mg/kg for > 96 hours
• Concurrent topical therapy, including psoralen and ultraviolet A irradiation (PUVA), glucocorticoid creams, oral beclomethasone dipropionate, topical azathioprine, or ophthalmic glucocorticoids allowed
• No other concurrent treatment for GVHD