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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Methotrexate and glucocorticoid therapy, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This phase II trial is studying how well giving methotrexate together with glucocorticoids works in treating patients with newly diagnosed acute graft-versus-host disease after donor stem cell transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Glucocorticoids; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

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