Clinical trial · Interventional

Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases

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

NCT00084695CI-TRIAL-00013399unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Childhood Langerhans Cell Histiocytosis	Childhood Langerhans Cell Histiocytosis	ONTOLOGY_EXACT	0.98
Fanconi Anemia	—	UNRESOLVED	—
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98
Unspecified Childhood Solid Tumor, Protocol Specific	Childhood Solid Neoplasm	ALIAS	0.85

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
anti-thymocyte globulin	Biological	—	UNRESOLVED
busulfan	Drug	Busulfan	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
fludarabine phosphate	Drug	Fludarabine	ALIAS
melphalan	Drug	Melphalan	ALIAS
methylprednisolone	Drug	—	UNRESOLVED
radiation therapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Regimen A
description
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.
interventionNames
1. Biological: anti-thymocyte globulin
2. Drug: cyclophosphamide
3. Radiation: radiation therapy
type
EXPERIMENTAL
label
Regimen B (patients who do not receive TBI)
description
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.
interventionNames
1. Biological: anti-thymocyte globulin
2. Drug: busulfan
3. Drug: melphalan

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 21 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Sep 1, 2003
Primary completion: Dec 1, 2012
Completion: —
First posted: Jun 11, 2004
Last update posted: Jan 10, 2014
Enrollment: 25 (estimated)
Lead sponsor: Milton S. Hershey Medical Center OTHER
Keywords: 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