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A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Children and Adults With Hematologic Malignancies (NCT00003661)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy or radiation therapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients who have hematologic cancer.
  • Biological: anti-thymocyte globulin
    • Drug: busulfan
      • Drug: cyclosporine
        • Drug: melphalan
          • Drug: methylprednisolone
            • Procedure: umbilical cord blood transplantation
              • Radiation: radiation therapy
                Ages eligible for Study
                up to 54 Years
                Genders eligible for Study
                All
                Accepts Healthy Volunteers
                No
                OBJECTIVES: I. Determine the rates of hematologic and immune reconstitution in pediatric patients with high risk hematologic malignancies in first remission or in second or subsequent remission, and adult patients with acute lymphocytic leukemia (ALL) or acute nonlymphocytic leukemia (ANLL) in second or subsequent remission, who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation. II. Determine the incidence of graft-versus-host disease in this setting. III. Determine whether contamination of umbilical cord blood with maternal cells is a clinical problem in this setting. IV. Describe the incidence of leukemic relapse in these patients after UCB transplantation. V. Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients. VI. Determine specifically whether larger recipients (greater than 40 kg) can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment.

                OUTLINE: Patients undergo a back-up bone marrow harvest prior to treatment. Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5, followed by melphalan IV on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV on days -3 to -1. If TBI is not allowed, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. On day 0, patients receive umbilical cord blood infusion. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months. Patients are followed indefinitely for survival and late toxicity.

                PROJECTED ACCRUAL: A minimum of 48 patients will be accrued into this study within 4 years.

                17 locations

                United States (17)
                • University of Florida Health Science Center
                  Gainesville, Florida, United States, 32610-0296
                • Division of Pediatric Surgery
                  Jacksonville, Florida, United States, 32207
                • Nemours Children's Clinic
                  Jacksonville, Florida, United States, 32207
                • H. Lee Moffitt Cancer Center and Research Institute
                  Tampa, Florida, United States, 33612
                • Rush-Presbyterian-St. Luke's Medical Center
                  Chicago, Illinois, United States, 60612
                • University of Chicago Cancer Research Center
                  Chicago, Illinois, United States, 60637
                • Children's Hospital of New Orleans
                  New Orleans, Louisiana, United States, 70118
                • Cardinal Glennon Children's Hospital
                  Saint Louis, Missouri, United States, 63104
                • Hackensack University Medical Center
                  Hackensack, New Jersey, United States, 07601
                • Roswell Park Cancer Institute
                  Buffalo, New York, United States, 14263-0001
                • North Shore University Hospital
                  Manhasset, New York, United States, 11030
                • New York Blood Center
                  New York, New York, United States, 10021
                • Lineberger Comprehensive Cancer Center, UNC
                  Chapel Hill, North Carolina, United States, 27599-7295
                • Duke Comprehensive Cancer Center
                  Durham, North Carolina, United States, 27710
                • St. Christopher's Hospital for Children
                  Philadelphia, Pennsylvania, United States, 19134-1095
                • Medical University of South Carolina
                  Charleston, South Carolina, United States, 29425-0721
                • University of South Carolina School of Medicine
                  Columbia, South Carolina, United States, 29203
                Status:
                completed
                Type:
                Interventional
                Phase:
                Start:
                31 May, 1998
                Updated:
                02 March, 2011
                Participants:
                3
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