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Protocol No. 2005LS036 Principal Investigator Brunstein, Claudio
Phase Phase II
Age Group Both Scope Local
Secondary Protocol No. MT2005-02
Title MT2005-02 Transplantation of Unrelated Donor Umbilical Cord Blood in Patients with Hematological Malignancies Using a Non-Myeloablative Preparative Regimen
Objective This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant, cyclosporine, and mycophenolate mofetil works in treating patients with hematologic cancer.
Treatment Patients are stratified according to disease and involves treatment with allopurinol, fludarabine, cyclophosphamide, TBI 200 cGy, umbilical cord blood transplant, immunosuppressive therapies, supportive care, growth factor support and management of slow engraftment and graft failure. After completion of study treatment, patients are followed periodically for 5 years.
Description Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
Key Eligibility Patients with hematological malignancies: acute leukemia in remission, chronic myelogenous leukemia, myelodysplastic syndromes (MDS) , large cell lymphoma, Hodgkin's lymphoma, multiple myeloma, lymphoplasmacytic lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, marginal zone B-cell lymphoma or follicular lymphoma, bone marrow failure syndromes, Burkitt lymphoma or natural killer cell malignancy.
Applicable Disease Sites Acute Lymphocytic Leukemia (ALL)
Acute myeloid leukemia (AML)
Bone Marrow
Chronic lymphocytic leukemia (CLL)
Chronic myeloid leukemia (CML)
Hematologic Malignancies
Hodgkin's Lymphoma
Lymphoid Leukemia
Myelodysplastic syndromes (MDS)
Myeloproliferative diseases (MPD)
Non-Hodgkin's Lymphoma
Therapies Involved Blood and Marrow Transplant
Chemotherapy
Total Body Irradiation (TBI)
Drugs Involved ANTI-THYMOCYTE GLOBULIN (ATGAM)
CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
FLUDARABINE (FLUDARA)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be no more than 69-years-old. Women who are pregnant or nursing are not eligible. Males and females of reproductive potential must agree to use effective contraception. Patients with known HIV positive serology or HIV infection are not eligible. Must meet organ function requirements. A signed informed consent and HIPAA authorization are required; assent form also required for minors.
Treatment Type Treatment
Contact Timothy Krepski Phone:612-273-2800
Email:tkrepsk1@fairview.org