Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
NCT ID: NCT01233921
Last Updated: 2014-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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PURPOSE: This randomized clinical trial studies palifermin in preventing chronic graft-versus-host disease in patients who have undergone donor stem cell transplant for hematologic cancer
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Detailed Description
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I. To evaluate the pharmacodynamic effects of palifermin on thymic function in patients at risk of chronic graft-vs-host disease (GVHD).
II. To evaluate the tolerability of palifermin in patients at risk of chronic GVHD.
OUTLINE: Patients are assigned to 1 of 2 groups based on whether they wish to receive palifermin or not.
GROUP 1: Patients receive palifermin intravenously (IV) on days 1-3 in the absence of unacceptable toxicity.
GROUP 2: Patients do not receive palifermin.
After completion of study treatment, patients are followed up on days 7, 14, 21, and 28.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (palifermin)
Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
palifermin
Given IV
flow cytometry
Correlative studies
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Arm II (no palifermin)
Patients do not receive palifermin.
flow cytometry
Correlative studies
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Interventions
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palifermin
Given IV
flow cytometry
Correlative studies
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current dose of prednisone at =\< 0.5 mg/kg or equivalent or no systemic glucocorticoid treatment
* Ability to remain under care at the Seattle Cancer Care Alliance (SCCA) for at least 28 days after enrollment in the study
* Able and willing to give informed consent
Exclusion Criteria
* Prior diagnosis of chronic GVHD requiring systemic immunosuppressive treatment
* Any prior local irradiation to a field that included the thymus (total body irradiation is allowed)
* History of thymectomy
* Use of rabbit antithymocyte globulin in the pretransplant conditioning regimen
* Use of a graft depleted of T cells
* Any evidence of recurrent or persistent malignancy after HCT
* Participation in another study with chronic GVHD as the primary endpoint
* Any prior history of carcinoma
* Any infection that is not improving during appropriate treatment
* History of palifermin intolerance
* A positive pregnancy test (women of child-bearing potential)
* Breast feeding
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Martin, Paul
OTHER
Responsible Party
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Martin, Paul
Member
Principal Investigators
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Paul Martin
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2010-01711
Identifier Type: REGISTRY
Identifier Source: secondary_id
2437.00
Identifier Type: -
Identifier Source: org_study_id
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