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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00295997 |
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this 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 clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: graft-versus-tumor induction therapy Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Non-Myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia |
Estimated Enrollment: | 35 |
Study Start Date: | May 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE:
NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan.
NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day 11).
After completion of study treatment, patients are followed periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | up to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Hematologic malignancy, including any of the following:
Acute myeloid leukemia (AML)* not curable with chemotherapy and meeting any of the following criteria:
Myelodysplasia* with any of the following high-risk features:
Acute lymphoblastic leukemia (ALL)* not curable with chemotherapy and meeting any of the following criteria:
Chronic lymphocytic leukemia (CLL) with high-risk features, including any of the following:
Follicular lymphoma with any of the following high-risk features:
Multiple myeloma
Other lymphoma that has failed to respond to primary therapy, progressed, or recurred after prior therapy, including any of the following:
Myeloproliferative disease with evidence of disease acceleration, including any of the following:
No rapid progression of malignant disease
Matched unrelated donor available
PATIENT CHARACTERISTICS:
Bilirubin < 3 mg/dL
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Principal Investigator: | Charles A. Linker, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000463522, UCSF-01251, UCSF-H5010-19585-05, UCSF-2101 |
Study First Received: | February 23, 2006 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00295997 |
Health Authority: | United States: Federal Government |
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) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic myelomonocytic leukemia |
chronic neutrophilic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes essential thrombocythemia juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative disease, unclassifiable polycythemia vera previously treated myelodysplastic syndromes recurrent adult acute myeloid leukemia prolymphocytic leukemia recurrent adult Hodgkin lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent/refractory childhood Hodgkin lymphoma |
Blast Crisis Chronic myelogenous leukemia Hodgkin lymphoma, adult Urogenital Neoplasms Tacrolimus Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Hemorrhagic thrombocythemia Neoplasm Metastasis Thrombocythemia, Hemorrhagic Methotrexate Kidney Diseases Myelodysplastic syndromes |
Essential thrombocytosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Carcinoma Folic Acid Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase Fludarabine Neoplasms, Glandular and Epithelial Precancerous Conditions |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Pathologic Processes Neoplasms by Site Syndrome Therapeutic Uses Abortifacient Agents Cardiovascular Diseases Alkylating Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |