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View Clinical Trial (Medical Research Study)
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A Phase 1 Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT - NCT00460421- (Clinical Trial 168213)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy168213.aspx
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Dallas |
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State:
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TX |
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| Conditions: |
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Leukemia |
| Purpose: |
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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]) followed by hematopoietic stem cell transplant (HSCT). The study will
evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses
(40 μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are be evaluated in each age group (1 to 2, 3
to 11, and 12 to 16 years, respectively) using a conventional dose escalation design.
Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before
the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following
HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well
tolerated, efficacious dose in each age group. Patients will also be followed for secondary
malignancies, progression-free survival (PFS) and overall survival (OS) for a maximum of 10
years
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. ALL or AML requiring HSCT
2. Age ≥ 1 and ≤ 16 years at screening
3. Lansky performance status > 60%
4. Candidate for allogeneic HSCT protocol:
- Adequate kidney function: Serum creatinine: ≤ 1.5 mg/dL or creatinine clearance
or radioisotope GFR ≥ 60 mL/min/1.73m2
- Adequate liver function: Serum total bilirubin: ≤ 2.0 mg/dl; AST/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 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)
5. Identification of an HLA-compatible donor per institutional standards
6. Assent from a minor (if the child is capable of giving assent) per Department of
Heath and Human Services (DHHS) guidelines listed in 21CFR 50.55 and local IRB
standards.
7. Serum amylase and lipase: ≤ 1.2 x IULN
8. Negative serum/urine pregnancy test for females with childbearing potential within 4
days before administration of the first palifermin dose
9. 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 Criteria:
1. Prior treatment with palifermin or other keratinocyte growth factors
2. Received an investigational product or device, with the exception investigational
stem cell separators, in another clinical trial within 30 days before enrollment.
3. Known to have a life threatening infection not responding well to treatment
4. Past history of veno-occlusive disease of the liver
5. 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].
6. Receiving glutamine or any other medication to reduce the incidence of OM within 30
days before enrollment
7. Previous or concurrent malignancy other than entry diagnostic criteria and/or solid
organ transplantation and/or treatment of congenital immunodeficiency
8. History of pancreatitis
9. Breastfeeding (giving) |
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| Study is available at: |
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Research Site
Dallas, TX
United States
Primary Contact:
Caroline Widlund, Bsc, R.N.
Email: caroline.widlund@biovitrum.com
Phone: +46 8 697 2000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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