Overview

Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Other Hematologic or Metabolic Diseases

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy or radiation therapy. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation in treating patients who have hematologic cancer or other hematologic or metabolic diseases.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antilymphocyte Serum
Busulfan
Cyclophosphamide
Cyclosporine
Cyclosporins
Melphalan
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of one of the following: -
Severe aplastic anemia with bone marrow cellularity less than 20% and at least 2 of the
following criteria: Granulocyte count less than 500/mm3 Platelet count less than 20,000/mm3
Reticulocyte count less than 50,000/mm3 Etiologies may be Fanconi's anemia, hypoplastic
leukemia, monosomy 7, drug exposure (chloramphenicol, NSAIDS), viral exposure (EBV,
hepatitis, parvovirus, HIV), nutritional deficiencies, thymoma, paroxysmal nocturnal
hemoglobinuria, and amegakaryocytic thrombocytopenia - Myelodysplastic syndrome (MDS) that
is refractory to medical management or with cytogenetic abnormalities predictive of
transformation into acute leukemia, including 5q-, 7q-, monosomy 7, and trisomy 8 De novo
primary or therapy-related secondary MDS Refractory anemia or refractory anemia with ringed
sideroblasts only - Inherited hematopoietic disorders that are refractory to medical
management Severe combined immunodeficiency Familial erythrophagocytic lymphohistiocytosis
Wiskott-Aldrich syndrome Kostmann's syndrome (infantile agranulocytosis) Chronic
granulomatous disease Leukocyte adhesion deficiency Chediak-Higashi syndrome Paroxysmal
nocturnal hemoglobinuria Fanconi's anemia Dyskeratosis congenita Diamond-Blackfan anemia
Amegakaryocytic thrombocytopenia Osteopetrosis Gaucher's disease Lesch-Nyhan syndrome
Mucopolysaccharidoses Lipidoses Must also meet all the following conditions: No HLA-ABC/DR
identical related bone marrow or UCB donor No 5/6 antigen matched related bone marrow or
UCB donor Condition precludes waiting to search and find a donor in the National Marrow
Donor Registry Must have backup autologous or haploidentical related marrow Must have
available serologic match umbilical cord blood unit in the New York Blood Center's
Placental Blood Project

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 OR Karnofsky or
Lansky 80-100% Life expectancy: At least 3 months Hematopoietic: See Disease
Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 4
times normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50
mL/min Cardiovascular: Shortening fraction or ejection fraction at least 80% of normal for
age Pulmonary: FVC and FEV1 at least 60% predicted for age Adults: DLCO at least 60%
predicted Other: No active concurrent malignancy No active infections at time of backup
bone marrow harvest or pretransplant cytoreduction Not pregnant or nursing Negative
pregnancy test HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent
cytotoxic chemotherapy Endocrine therapy: No concurrent immunosuppressive medications
Radiotherapy: No concurrent radiotherapy Surgery: Not specified