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The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Childhood Langerhans Cell Histiocytosis, Fanconi Anemia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Impact of the use of umbilical cord blood as a source of hematopoietic stem cells

Safety Issue:

No

Principal Investigator

Kenneth G. Lucas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

Unspecified

Study ID:

CDR0000365544

NCT ID:

NCT00084695

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Childhood Langerhans Cell Histiocytosis
  • Fanconi Anemia
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • childhood myelodysplastic syndromes
  • recurrent childhood rhabdomyosarcoma
  • unspecified childhood solid tumor, protocol specific
  • previously treated childhood rhabdomyosarcoma
  • previously untreated childhood rhabdomyosarcoma
  • disseminated neuroblastoma
  • regional neuroblastoma
  • recurrent neuroblastoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent childhood acute lymphoblastic leukemia
  • juvenile myelomonocytic leukemia
  • childhood acute lymphoblastic leukemia in remission
  • childhood Burkitt lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • previously treated myelodysplastic syndromes
  • Fanconi anemia
  • de novo myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • childhood Langerhans cell histiocytosis
  • recurrent childhood acute myeloid leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • Anemia
  • Fanconi Anemia
  • Fanconi Syndrome
  • Histiocytosis
  • Histiocytosis, Langerhans-Cell
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neuroblastoma
  • Lymphoma, Non-Hodgkin
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850