Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia - Full Text View

Sponsors and Collaborators:	Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008164

Purpose

RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.

Condition	Intervention	Phase
Langerhans Cell Histiocytosis Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Procedure: umbilical cord blood transplantation	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Transplantation Using Umbilical Cord And Placental Blood

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Survival [ Designated as safety issue: No ]
Incidence of graft-versus-host disease [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 1997

Detailed Description:

OBJECTIVES:

Determine the response rate of patients with chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder treated with allogeneic umbilical cord and placental blood transplantation.
Determine the toxicity of this regimen in these patients.
Determine survival in these patients treated with this regimen.
Determine the incidence of graft-versus-host disease in these patients treated with this regimen.

OUTLINE: Patients receive a standard preparative regimen for their disease. Following the preparative regimen patients undergo umbilical cord blood stem cell transplantation on day 0.

Patients are followed every 1-2 weeks for 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 4-5 years.

Eligibility

Ages Eligible for Study:	up to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder
Eligible for allogeneic bone marrow transplantation, but lacking a donor
Available donor umbilical cord blood that is mismatched on no more than 2 HLA loci
- HIV negative
- Hepatitis B surface antigen and hepatitis C negative

PATIENT CHARACTERISTICS:

Age:

Under physiologic 60

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin less than 2 times normal
No severe hepatic disease
Hepatitis B surface antigen and hepatitis C negative

Renal:

Creatinine less than 2 times normal

Other:

HIV negative
Not pregnant or nursing
No other serious medical or psychiatric illness that would preclude study compliance
No serious infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008164

Locations

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

David G. Savage, MD

Herbert Irving Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Styczynski J, Cheung YK, Garvin J, Savage DG, Billote GB, Harrison L, Skerrett D, Wolownik K, Wischhover C, Hawks R, Bradley MB, Del Toro G, George D, Yamashiro D, van de Ven C, Cairo MS. Outcomes of unrelated cord blood transplantation in pediatric recipients. Bone Marrow Transplant. 2004 Jul;34(2):129-36.

Study ID Numbers:	CDR0000068384, CPMC-IRB-7934, CPMC-CAMP-021, NCI-G00-1899
Study First Received:	January 6, 2001
Last Updated:	November 16, 2008
ClinicalTrials.gov Identifier:	NCT00008164
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
Langerhans cell histiocytosis
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia

blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
recurrent/refractory childhood Hodgkin lymphoma
stage I adult Burkitt lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma

Study placed in the following topic categories:

Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Langerhans cell histiocytosis
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Mycoses
Letterer-Siwe disease
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Lung Diseases, Interstitial
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Acute myelogenous leukemia
Myeloproliferative Disorders

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type

Reticuloendotheliosis
Immune System Diseases
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009