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Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

This study has been completed.

Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004232
  Purpose

RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Drug: cyclosporine
Drug: filgrastim
Drug: methylprednisolone
Drug: prednisone
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Fungal Infections    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

Drug Information available for:   Filgrastim    Methylprednisolone    Prednisone    Cyclosporine    Cyclosporin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies

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

Study Start Date:   October 1999

Detailed Description:

OBJECTIVES:

  • Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation.
  • Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population.

OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.

Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover.

Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols
  • HLA-identical or one antigen-mismatched related donor

PATIENT CHARACTERISTICS:

Age:

  • 10 to 65

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No known sensitivity to E. coli derivatives

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004232

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University    
      Chicago, Illinois, United States, 60611-3013

Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Richard K. Burt, MD     Robert H. Lurie Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000067474, NU-96H4, NCI-G99-1660
First Received:   January 28, 2000
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00004232
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma  
stage II adult Hodgkin lymphoma  
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
monoclonal gammopathy of undetermined significance  
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
stage I cutaneous T-cell non-Hodgkin lymphoma  
stage II cutaneous T-cell non-Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
Burkitt lymphoma  
isolated plasmacytoma of bone  
extramedullary plasmacytoma  
refractory multiple myeloma
stage 0 chronic lymphocytic leukemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia

Study placed in the following topic categories:
Blast Crisis
Prednisone
Sezary syndrome
Cyclosporine
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Small non-cleaved cell lymphoma
Cyclosporins
Lymphoma, large-cell, immunoblastic
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Myelodysplastic syndromes
Essential thrombocytosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Plasmacytoma
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neuroprotective Agents
Pathologic Processes
Therapeutic Uses
Antifungal Agents
Syndrome
Cardiovascular Diseases
Dermatologic Agents
Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 20, 2008




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