Status:
UNKNOWN
Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Childhood Langerhans Cell Histiocytosis
Fanconi Anemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
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 umbilic...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00084695
Start Date
September 1 2003
Last Update
January 10 2014
Active Locations (1)
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1
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850