Status:
COMPLETED
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Oral Mucositis
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
Brief Summary
Mucositis is a well-known complication of both autologous and allogeneic hematopoietic stem cell transplantation (HSCT). Many who suffer this disorder require total parental nutrition and intravenous ...
Detailed Description
Secondary objectives of this study include exploring the pharmacoeconomics of palifermin in this particular patient population through an assessment of inpatient days, intravenous nutrition, and analg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Female - pregnant (negative serum or urine pregnancy test within 14 days prior to enrollment).
- Female - lactating.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00701688
Start Date
September 1 2007
End Date
February 1 2012
Last Update
March 23 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105