Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant
NCT ID: NCT00361049
Last Updated: 2010-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2004-09-30
2010-11-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of donor mesenchymal stem cells in treating patients with acute or chronic graft-versus-host disease after undergoing a donor stem cell transplant.
Detailed Description
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Primary
* Determine the safety of donor mesenchymal stem cell (MSC) infusion in patients with acute or extensive chronic graft-vs-host disease (GVHD) after undergoing HLA-identical sibling donor stem cell transplant.
Secondary
* Describe the rates of complete and partial resolution of GVHD when MSCs are used in addition to the standard GVHD therapy.
* Determine inflammatory cytokine levels, lymphocyte subsets, and donor-reactive lymphocyte numbers in blood of patients with acute GVHD prior to therapy and at 7 and 14 days post-MSC therapy.
* Determine if donor MSCs engraft in tissues inflamed by GVHD in patients who have undergone gender-mismatched transplantation.
OUTLINE: This is a multicenter, dose-escalation study of donor mesenchymal stem cells (MSC).
Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
Cohorts of 3-6 patients receive escalating doses of donor MSCs until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Blood samples are obtained periodically and examined by immunoenzyme techniques for mixed lymphocyte reaction (as a surrogate marker for alloreactivity) and cytokine levels (TH1 \[i.e., interleukin (IL)-2 and interferon-gamma\], TH2 \[i.e., IL-10 and IL-4\], and inflammatory cytokines \[i.e., tumor necrosis factor-alpha and IL-1\]). Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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graft versus host disease prophylaxis/therapy
Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
fluorescence in situ hybridization
Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
immunoenzyme technique
Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
immunohistochemistry staining method
Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
laboratory biomarker analysis
Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.
in vitro-treated bone marrow transplantation
Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.
management of therapy complications
Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.
Eligibility Criteria
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Inclusion Criteria
* Developed acute graft-vs-host disease (GVHD) of clinical grade II-IV or extensive chronic GVHD after undergoing HLA-identical sibling donor hematopoietic stem cell transplant for any indication, malignant or nonmalignant
* Requires systemic immunosuppressive therapy with systemic corticosteroids (methylprednisone dose 2 mg/kg/day or equivalent) and concurrent cyclosporine or tacrolimus
* May have been enrolled on an institutional allogeneic stem cell transplant protocol using either ablative or nonmyeloablative preparative regimens
* No evidence of relapsed or progressive malignant disease at the time of GVHD
PATIENT CHARACTERISTICS:
* Not pregnant
* Negative pregnancy test
* Creatinine clearance ≥ 20 mL/min
* Oxygen saturation ≥ 90% on room air
* No severe or symptomatic restrictive or obstructive lung disease or respiratory failure requiring ventilator support
* No uncontrolled hypertension or congestive heart failure, active angina pectoris requiring the use of nitrates, myocardial infarction within the past 6 months, or major ventricular arrhythmia or cardiac failure requiring active treatment
* No significant organ dysfunction
* No active severe infections, including sepsis, pneumonia with hypoxemia, persistent bacteremia, or meningitis
* Fever without a source is allowed
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Principal Investigators
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Hillard M. Lazarus, MD
Role: PRINCIPAL_INVESTIGATOR
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Locations
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Geauga Regional Hospital
Cleveland, Ohio, United States
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
University Suburban Health Center
Cleveland, Ohio, United States
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States
Southwest General Health Center
Cleveland, Ohio, United States
UHHS Westlake Medical Center
Cleveland, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE-CWRU-3Y03
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU3Y03
Identifier Type: -
Identifier Source: org_study_id