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Phase I Study Of The Use Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation


Phase 1
2 Years
18 Years
Not Enrolling
Both
Oral Mucositis, Hematopoietic Stem Cell Transplantation

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Trial Information

Phase I Study Of The Use Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation


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 analgesia requirements within 100 days post-transplantation. We will also
explore the research participants' rates of immune reconstitution, specifically T and
B-lymphocytes and NK cells, within the first year of HSCT.


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.

Exclusion Criteria:

- Female - pregnant (negative serum or urine pregnancy test within 14 days prior to
enrollment).

- Female - lactating.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and describe the toxicity profile of palifermin in pediatric research participants with hematologic malignancies undergoing first HSCT.

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Ashok Srinivasan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

PALSCT

NCT ID:

NCT00701688

Start Date:

September 2007

Completion Date:

February 2012

Related Keywords:

  • Oral Mucositis
  • Hematopoietic Stem Cell Transplantation
  • Mucositis, Oral
  • Hematopoietic Stem Cell Transplantation
  • Allogeneic Transplantation
  • Pharmacokinetics
  • Maximum Tolerated Dose
  • Stomatitis
  • Mucositis

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794