Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Inclusion Criteria

• •Age greater than or equal to 2 years and less than 18 years of age.
• •Diagnosis of a hematologic malignancy.
• •Has not received a prior autologous or allogeneic HSCT.
• •Is scheduled to receive either a matched family member or MUD bone marrow stem cell graft at St. Jude Children's Research Hospital. A matched family member donor is defined as a sibling matched at 5 or 6 HLA loci or another related donor matched at 6 HLA loci.
• •Is scheduled to receive a myeloablative preparative regimen (cyclophosphamide/TBI based) prior to the infusion of the allogeneic graft.
• •Cardiac shortening fraction greater than or equal to 25%.
• •Serum creatinine is less than twice the upper limit of normal for age.
• •Bilirubin less than 3.0 mg/dl.
• •Aspartate transaminase (AST) less than 500 IU/ml.
• •Alanine transaminase (ALT) less than 500 IU/ml.
• •Amylase less than 1.5 times the upper limits of normal for age.
• •Lipase less than 1.5 times the upper limits of normal for age.
• •Forced vital capacity (FVC) greater than or equal to 40% of predicted value or pulse oximetry greater than or equal to 92% on room air.
• •No known hypersensitivity to E coli-derived proteins or palifermin.
• •No active or recent (within 30 days prior to enrollment) gastrointestinal bleeding.
• •No active or recent (within 30 days prior to enrollment) oral ulcerations.
• •No active fungal infection, bacteremia or viremia within two weeks prior to enrollment.