View Clinical Trial (Medical Research Study)
The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Childhood Langerhans Cell Histiocytosis - Fanconi Anemia - Leukemia - Lymphoma - Myelodysplastic Syndromes - Neuroblastoma - Sarcoma - Unspecified Childhood Solid Tumor, Protocol Specific |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine the impact of the use of umbilical cord blood as a source of hematopoietic
stem cells for children with life-threatening oncologic, hematologic, or
genetic/metabolic disorders in need of a stem cell transplant.
- Compare the incidence of graft-versus-host disease in patients receiving cord blood
transplants in this study with historical data for unrelated donor stem cell
transplants.
- Compare the incidence of engraftment in patients receiving cord blood transplants in
this study with historical data for unrelated donor stem cell transplants.
OUTLINE:
- Preparative therapy: Patients are treated on 1 of 4 preparative therapy regimens.
- Regimen A: 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): 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 and related disorders): 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: 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.
- 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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| Criteria: |
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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:
- > 100,000/mm^3 for patients 6-12 months of age
- > 50,000/mm^3 for patients 10-20 years of age
- > 20,000/mm^3 for patients 21 years of age
- 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:
- Neuroblastoma
- Ewing's sarcoma
- Rhabdomyosarcoma
- 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:
- Severe combined immune deficiency
- Wiskott-Aldrich
- 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
- 21 and under
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
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| NCT ID: |
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NCT00084695 |
| Primary Contact: |
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Study Chair
Kenneth G. Lucas, MD
Penn State Children's Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Hershey, Pennsylvania 17033
United States
Kenneth G. Lucas, MD
Phone: 717-531-6012
Email: klucas@psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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