Recruiting

Phase 2

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

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT00084695

Conditions

Childhood Langerhans Cell Histiocytosis

Fanconi Anemia

Leukemia

Lymphoma

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

anti-thymocyte globulin

busulfan

cyclophosphamide

fludarabine phosphate

melphalan

Study Details

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 umbilical cord blood works as a source of stem cells in treating patients with types of cancer as well as other diseases.

Conditions

Childhood Langerhans Cell Histiocytosis

Fanconi Anemia

Leukemia

Lymphoma

Myelodysplastic Syndromes

Study ID

NCT00084695

Start date

Sep, 2003

Status verified date

Oct, 2008

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: Regimen C (patients with Fanconi's anemia/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.

experimental: 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.

Interventions

anti-thymocyte globulin

Given IV

busulfan

Given orally

cyclophosphamide

Given IV

fludarabine phosphate

Given IV

melphalan

Given IV

methylprednisolone

Given IV

radiation therapy

Patients undergo radiation therapy two times daily on days -7 to -4.

Primary outcome measure

Impact of the use of umbilical cord blood as a source of hematopoietic stem cells [ Time Frame: undefined ]
Comparison of the incidence of graft-vs-host disease with historical data [ Time Frame: undefined ]
Comparison of the incidence of engraftment with historical data [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Kenneth G. Lucas, MD

717-531-6012 klucas@psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Jan 10, 2014

Last verified

Oct, 2008

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2014-01-10.