Status:
COMPLETED
Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief 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. ...
Detailed Description
OBJECTIVES: * Determine, within the limits of a phase II study, whether low-dose methotrexate can accelerate withdrawal of glucocorticoids and decrease nonrelapsing mortality in patients with newly d...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00357084
Start Date
May 1 2006
Last Update
September 14 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024