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Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00008164
First Posted: January 27, 2003
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
January 6, 2001
January 27, 2003
December 18, 2013
January 1997
Not Provided
  • Response rate
  • Toxicity
  • Survival
  • Incidence of graft-versus-host disease
Not Provided
Complete list of historical versions of study NCT00008164 on ClinicalTrials.gov Archive Site
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Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
Transplantation Using Umbilical Cord And Placental Blood

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Childhood Langerhans Cell Histiocytosis
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
Procedure: umbilical cord blood transplantation
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Not Provided
Not Provided

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
Sexes Eligible for Study: All
up to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00008164
CDR0000068384
CPMC-IRB-7934
CPMC-CAMP-021
NCI-G00-1899
Not Provided
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Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: David G. Savage, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP