Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00365287 |
RATIONALE: Giving low doses of chemotherapy and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with total-body irradiation before donor umbilical cord blood transplant and to see how well they work in treating patients with advanced hematologic cancer, metastatic breast cancer, or kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: radiation therapy Procedure: umbilical cord blood transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen |
Estimated Enrollment: | 120 |
Study Start Date: | June 2000 |
OBJECTIVES:
Primary
Secondary
OUTLINE:
NOTE: *Patients who have not had prior combination chemotherapy within the past 3 months OR who only received 1 prior induction course for the treatment of acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndromes, or chronic myelogenous leukemia in blast crisis receive ATG during the preparative regimen.
After transplantation, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Ages Eligible for Study: | up to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
In first complete remission (CR1) by morphology AND at high risk, as evidenced by 1 of the following:
Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
In CR1 by morphology AND at high risk, as evidenced by 1 of the following:
Chronic myelogenous leukemia
Non-Hodgkin's lymphoma (NHL)
Hodgkin's lymphoma
MDS
Less than 5% blasts
Metastatic breast cancer
Must have a 4/6 HLA-A, -B, and -DRB1 matched unrelated umbilical cord blood donor available
PATIENT CHARACTERISTICS:
Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatric patients)
No active, serious infection
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000450906, UMN-2000LS039, UMN-MT2000-15 |
Study First Received: | August 16, 2006 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00365287 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia accelerated phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory anemia adult acute lymphoblastic leukemia in remission blastic phase chronic myelogenous leukemia |
Blast Crisis Cyclosporine Chronic myelogenous leukemia Refractory anemia Miconazole Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Urologic Neoplasms Cyclosporins Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders |
Anemia, Refractory Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis Acute myeloid leukemia, adult Kidney Diseases Hodgkin Disease Breast Diseases Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Pathologic Processes Neoplasms by Site Syndrome Therapeutic Uses Antifungal Agents Cardiovascular Diseases |
Alkylating Agents Dermatologic Agents Disease Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |