Status:
COMPLETED
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Leukemia
Eligibility:
All Genders
1-16 years
Phase:
PHASE1
Brief Summary
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation \[TBI\]) foll...
Eligibility Criteria
Inclusion
- Acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) requiring HSCT
- Age ≥ 1 and ≤ 16 years at screening
- Lansky performance status \> 60%
- Candidate for allogeneic HSCT protocol:
- Adequate kidney function: Serum creatinine: ≤ 1.5 mg/dL or creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL/min/1.73m2
- Adequate liver function: Serum total bilirubin: ≤ 2.0 mg/dl; aspartate transaminase (AST)/alanine aminotransferase (ALT) ≤ 4.0 x institutional upper limits of normal (IULN); Albumin ≥ 2 g/dL
- Adequate cardiac function: shortening fraction \> 29% documented by echocardiogram, or ejection fraction ≥ 50% documented by multigated acquisition scan (MUGA).
- Adequate pulmonary function documented by corrected lung diffusion capacity test (DLCO) \> 50% or oxygen saturation of ≥ 92% on room air if unable to perform pulmonary function tests
- Negative for human immunodeficiency virus (HIV), hepatitis C virus (HCV), human T cell lymphotropic virus (HTLV)
- Identification of an HLA-compatible donor per institutional standards
- Assent from a minor (if the child is capable of giving assent) per Department of Health and Human Services (DHHS) guidelines listed in 21CFR 50.55 and local Institutional Review Board (IRB) standards.
- Serum amylase and lipase: ≤ 1.2 x IULN
- Negative serum/urine pregnancy test for females with childbearing potential within 4 days before administration of the first palifermin dose
- Agreement by males and females of reproductive potential to use an effective means of contraception 30 days prior to enrollment through Day +30 (end of treatment)
Exclusion
- Prior treatment with palifermin or other keratinocyte growth factors
- Received an investigational product or device, with the exception investigational stem cell separators, in another clinical trial within 30 days before enrollment.
- Known to have a life threatening infection not responding well to treatment
- Past history of veno-occlusive disease of the liver
- Known sensitivity to any Escherichia coli-derived products with grade 3 to 4 allergies to L-asparaginase \[grade 1 to 2 allergies to L-asparaginase will be allowed\].
- Receiving glutamine or any other medication to reduce the incidence of oral mucositis (OM) within 30 days before enrollment
- Previous or concurrent malignancy other than entry diagnostic criteria and/or solid organ transplantation and/or treatment of congenital immunodeficiency
- History of pancreatitis
- Breastfeeding (giving)
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00460421
Start Date
August 1 2006
End Date
May 1 2011
Last Update
December 5 2014
Active Locations (7)
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1
Arizona Cancer Center
Tucson, Arizona, United States
2
Loma Linda University
Loma Linda, California, United States
3
Children´s Hospital
Los Angeles, California, United States
4
Regents of University of California
Los Angeles, California, United States