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| ID | Type | Description | Link |
|---|---|---|---|
| PSCI-2003-232 |
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RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.
PURPOSE: This phase II trial is studying how well umbilical cord blood works as a source of stem cells in treating patients with types of cancer as well as other diseases.
OBJECTIVES:
Primary
OUTLINE:
Preparative therapy: Patients are treated on 1 of 4 preparative therapy regimens.
Cord blood transplant: All patients undergo umbilical cord blood transplantation on day 0.
Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily beginning on day -1. Patients also receive methylprednisolone IV twice daily beginning on day 5 and continuing until at least day 28.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Patients undergo total body irradiation (TBI) two times daily on days -7 to -4. Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin (ATG) IV over at least 6 hours on days -3 to -1. |
|
| Regimen B (patients who do not receive TBI) | Experimental | Patients receive oral busulfan 4 times daily on days -8 to -5, and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2. |
|
| Regimen C (patients with Fanconi's anemia/related disorders) | Experimental | Patients undergo TBI on day -6. Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2. |
|
| Regimen D | Experimental | Patients receive oral or IV busulfan 4 times daily on days -9 to -5, ATG IV over at least 6 hours on days -5 to -3, and cyclophosphamide IV over 30-60 minutes on days -5 to -2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the use of umbilical cord blood as a source of hematopoietic stem cells | ||
| Comparison of the incidence of graft-vs-host disease with historical data | ||
| Comparison of the incidence of engraftment with historical data |
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DISEASE CHARACTERISTICS:
Diagnosis of malignant or non-malignant disease, including but not limited to any of the following:
Acute myeloid leukemia or acute lymphoblastic leukemia (ALL) with resistant disease beyond first clinical remission (CR)
ALL in first CR at high-risk because of 1 of the following factors:
Hypoploidy
Pseudodiploidy with translocations t(9;22), t(4;11), or t(8;14)
Elevated WBC at diagnosis as follows:
Burkitt's lymphoma/leukemia
Chronic myelogenous leukemia in first chronic phase or beyond
Juvenile myelomonocytic leukemia
Advanced stage or relapsed lymphoma
Advanced stage or relapsed solid tumors, including any of the following:
Myelodysplastic syndromes, excluding patients with grade 3 or 4 myelofibrosis
Familial erythrophagocytic histiocytosis
Histiocytosis unresponsive to medical management
Inborn errors of metabolism
Langerhans cell histiocytosis unresponsive to medical management
Immune deficiencies, including:
Hemoglobinopathies, including sickle cell disease and thalassemia
Severe aplastic anemia
Fanconi's anemia
Metabolic storage diseases
Unrelated cord blood donor must be HLA-identical OR may be mismatched for 1, 2, or 3 HLA-loci (A, B, DR)
No other existing HLA-identical related donor available at the time of transplantation
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth G. Lucas, MD | Milton S. Hershey Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033-0850 | United States |
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| busulfan | Drug | Given orally |
|
| cyclophosphamide | Drug | Given IV |
|
| fludarabine phosphate | Drug | Given IV |
|
| melphalan | Drug | Given IV |
|
| methylprednisolone | Drug | Given IV |
|
| radiation therapy | Radiation | Patients undergo radiation therapy two times daily on days -7 to -4. |
|
| ID | Term |
|---|---|
| D005199 | Fanconi Anemia |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D002051 | Burkitt Lymphoma |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D029502 | Anemia, Hypoplastic, Congenital |
| D000741 | Anemia, Aplastic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080984 | Congenital Bone Marrow Failure Syndromes |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D008775 | Methylprednisolone |
| D011878 | Radiotherapy |
| 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 |
| 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 |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013812 | Therapeutics |
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