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| ID | Type | Description | Link |
|---|---|---|---|
| UCSF-01251 | |||
| UCSF-H5010-19585-05 | |||
| UCSF-2101 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | |||
| filgrastim | Biological | |||
| graft-versus-tumor induction therapy | Biological | |||
| therapeutic allogeneic lymphocytes | Biological | |||
| busulfan | Drug | |||
| cyclophosphamide | Drug | |||
| fludarabine phosphate | Drug |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Aplastic anemia not responsive to immunosuppressive therapy
Metastatic renal cell carcinoma
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:
Chronic myeloid leukemia (CML) that failed to be controlled by imatinib mesylate
Disease must be stable or responding to therapy
No rapid progression of malignant disease
Not eligible for autologous stem cell transplantation
Matched unrelated donor available
PATIENT CHARACTERISTICS:
Creatinine < 2.0 mg/dL
Creatinine clearance > 40 mL/min
Bilirubin < 3 mg/dL
AST < 4 times upper limit of normal
Hepatitis C or B allowed provided bilirubin and AST are normal
Cardiac ejection fraction > 30%
DLCO > 40% of predicted
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled active infection requiring ongoing antibiotic treatment
No poor performance status
No poor organ function
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Charles A. Linker, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States | ||
| Wake Forest University Comprehensive Cancer Center |
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| methotrexate | Drug |
| mycophenolate mofetil | Drug |
| tacrolimus | Drug |
| allogeneic bone marrow transplantation | Procedure |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| Winston-Salem |
| North Carolina |
| 27157-1096 |
| United States |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D000013 | Congenital Abnormalities |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D001752 | Blast Crisis |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D013920 | Thrombocythemia, Essential |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D011087 | Polycythemia Vera |
| D015470 | Leukemia, Myeloid, Acute |
| D015463 | Leukemia, Prolymphocytic |
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D012008 | Recurrence |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D007945 | Leukemia, Lymphoid |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D015448 | Leukemia, B-Cell |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D000069585 | Filgrastim |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| D009173 | Mycophenolic Acid |
| D016559 | Tacrolimus |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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