Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant

• Status: Completed
• Trial end date: 2013-02-12
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Allopurinol; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Etoposide; Fludarabine; Methotrexate; Rasburicase; Sirolimus; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Patients with hematologic malignancies for whom conventional myeloablative allogeneic stem cell transplantation is deemed clinically appropriate and who are eligible for conventional myeloablative allogeneic stem cell transplantation on treatment plans/protocols, including any of the following:

• Non-Hodgkin lymphoma or Hodgkin lymphoma (relapsed or refractory disease)

• Chronic lymphocytic leukemia (received more than one previous treatment regimen)

• Acute myelogenous or lymphoblastic leukemia (AML/ALL) (high-risk disease, in first complete remission [CR1] or subsequent remission, or primary refractory disease)

• Chronic myelogenous leukemia in tyrosine-kinase resistant chronic phase, accelerated or blast phase, or primary refractory disease

• Myelodysplastic syndromes in International Prognostic Scoring System (IPSS) high-intermediate or high-risk groups

• Other hematologic disorders for which allogeneic stem cell transplantation is appropriate (e.g., myelofibrosis)

• Patients who have relapsed after standard autologous and/or allogeneic bone marrow transplant are eligible

• Must be receiving filgrastim (G-CSF)-mobilized related or unrelated donor allogeneic peripheral blood stem cells

• Patients receiving hematopoietic stem cells of any other sources such as a marrow graft or umbilical cord blood will not be eligible for this study

• Donor must be HLA-genotypically or phenotypically 6 of 6 antigen matched (at the A, B, DR loci) related or unrelated

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Patients with a "currently active" second malignancy other than non-melanoma skin cancers can only be registered if survival from the second malignancy is expected to be more than 1 year

• Ejection fraction ≥ 45% by either radioisotope Multiple Gated Acquisition Scan (MUGA) scan or Echocardiogram (ECHO)

• Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ≥ 50% of predicted with no symptomatic pulmonary disease

• Mini Mental Status Exam Score ≥ 20

• Patients must have an expected life expectancy of at least 3 months

• Patients with symptomatic visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled

• Patients with a fungal infection must have had treatment for at least one month and must have proof of regression of the infection prior to enrollment

• Patients may be on antibiotics at the time of transplant

Exclusion criteria:

• Human Immunodeficiency Virus (HIV) infection

• Uncontrolled diabetes mellitus

• Active congestive heart failure from any cause

• Previous history of congestive heart failure allowed

• Active angina pectoris

• Oxygen-dependent obstructive pulmonary disease

• Failure to demonstrate adequate compliance with medical therapy and follow-up

• Known history of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics