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A Multicenter Study of Unrelated Umbilical Cord Blood as an Alternate Source of Stem Cells for Transplantation (NCT00003913)

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation plus combination chemotherapy in treating patients who have hematologic cancer or nonmalignant hematologic disease.
  • Biological: anti-thymocyte globulin
    • Biological: filgrastim
      • Drug: busulfan
        • Drug: cyclophosphamide
          • Drug: methylprednisolone
            • Procedure: umbilical cord blood transplantation
              • Radiation: radiation therapy
                Ages eligible for Study
                up to 18 Years
                Genders eligible for Study
                All
                Accepts Healthy Volunteers
                No
                OBJECTIVES:

                - Determine the efficacy of umbilical cord blood transplantation, as measured by durable neutrophil engraftment, in patients with malignant or nonmalignant hematological disease.

                - Determine the disease-free survival and long-term survival in patients treated with this regimen.

                - Determine the incidence of neutrophil engraftment, primary and secondary graft failure, platelet engraftment, and RBC engraftment in patients treated with this regimen.

                - Determine the incidence and severity of acute and chronic graft-versus-host disease, complications (infection, veno-occlusive disease, interstitial pneumonitis), relapse, other malignancies, lymphoproliferative disorders, and posttransplantation myelodysplasia in patients treated with this regimen.

                - Determine the immune reconstitution in patients treated with this regimen.

                OUTLINE: This is a multicenter study. Patients are stratified according to disease group (malignant vs nonmalignant). Patients with malignant disease are further stratified according to quality of HLA match (1 or 2/6 vs 3/6 vs 4/6 vs 5/6 or 6/6), cell dose, and age.

                Patients are assigned to one of three conditioning regimens, depending on disease.

                - Group A (malignant disease ): Patients undergo total body irradiation (TBI) once on day -8 and twice daily on days -7 to -4. Male patients with acute lymphocytic leukemia (ALL) undergo radiotherapy boost to testes. Patients receive cyclophosphamide (CTX) IV on days -3 and -2 and methylprednisolone (MePRDL) IV and anti-thymocyte globulin (ATG) IV on days -3 to -1.

                - Group B (inborn errors of metabolism/storage disease): Patients receive oral busulfan (BU) every 6 hours on days -6 and -5, CTX IV on days -4 and -3, and MePRDL IV and ATG IV every 12 hours on days -2 and -1.

                - Group C (other nonmalignant diseases): Patients receive oral BU every 6 hours on days -9 to -6, CTX IV on days -5 to -2, and MePRDL IV and ATG IV on days -3 to -1.

                Patients in all groups receive cord blood IV over a maximum of 30 minutes on day 0. Patients also receive MePRDL IV with the first half of the infusion administered immediately before the cord blood infusion and filgrastim (G-CSF) IV beginning 4 hours after transplantation and continuing until blood counts recover.

                Patients are followed at 30, 60, and 90 days; at 6 months; and then annually thereafter.

                PROJECTED ACCRUAL: Approximately 390 patients will be accrued for this study within 5 years.

                23 locations

                United States (23)
                • City of Hope Comprehensive Cancer Center
                  Not specified
                  Duarte, California, United States, 91010-3000
                • Children's Hospital Los Angeles
                  Not specified
                  Los Angeles, California, United States, 90027-0700
                • Jonsson Comprehensive Cancer Center, UCLA
                  Not specified
                  Los Angeles, California, United States, 90095-1781
                • Children's Hospital of Orange County
                  Not specified
                  Orange, California, United States, 92868
                • Children's National Medical Center
                  Not specified
                  Washington, District of Columbia, United States, 20010-2970
                • Indiana University Cancer Center
                  Not specified
                  Indianapolis, Indiana, United States, 46202-5289
                • Children's Hospital of New Orleans
                  Not specified
                  New Orleans, Louisiana, United States, 70118
                • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
                  Not specified
                  Bethesda, Maryland, United States, 20892-1182
                • Warren Grant Magnuson Clinical Center
                  Not specified
                  Bethesda, Maryland, United States, 20892-1182
                • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
                  Not specified
                  Boston, Massachusetts, United States, 02115
                • Spectrum Health and DeVos Children's Hospital
                  Not specified
                  Grand Rapids, Michigan, United States, 49503
                • University of Minnesota Cancer Center
                  Not specified
                  Minneapolis, Minnesota, United States, 55455
                • Children's Mercy Hospital
                  Not specified
                  Kansas City, Missouri, United States, 64108
                • Cardinal Glennon Children's Hospital
                  Not specified
                  Saint Louis, Missouri, United States, 63104
                • Cancer Center at Hackensack University Medical Center
                  Not specified
                  Hackensack, New Jersey, United States, 07601
                • North Shore University Hospital
                  Not specified
                  Manhasset, New York, United States, 11030
                • James P. Wilmot Cancer Center at University of Rochester Medical Center
                  Not specified
                  Rochester, New York, United States, 14642
                • Duke Comprehensive Cancer Center
                  Not specified
                  Durham, North Carolina, United States, 27710
                • Cincinnati Children's Hospital Medical Center
                  Not specified
                  Cincinnati, Ohio, United States, 45229
                • Ireland Cancer Center
                  Not specified
                  Cleveland, Ohio, United States, 44106-5065
                • Children's Hospital of Pittsburgh
                  Not specified
                  Pittsburgh, Pennsylvania, United States, 15213
                • Medical City Dallas Hospital
                  Not specified
                  Dallas, Texas, United States, 75230
                • Fred Hutchinson Cancer Research Center
                  Not specified
                  Seattle, Washington, United States, 98109
                Status:
                completed
                Type:
                Interventional
                Phase:
                Start:
                30 November, 1998
                Updated:
                30 March, 2010
                Participants:
                390
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