Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease

This study has been completed.
Sponsor:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00118326
First received: July 8, 2005
Last updated: May 12, 2010
Last verified: May 2010

July 8, 2005
May 12, 2010
August 2003
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Safety and feasibility [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00118326 on ClinicalTrials.gov Archive Site
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Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease
Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant

RATIONALE: A bone marrow transplant from a brother or sister may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Colony-stimulating factors, such as G-CSF, cause the body to make blood cells. Giving G-CSF to the donor may help the body make more stem cells that can be collected for bone marrow transplant and may cause fewer side effects in the patient after the transplant.

PURPOSE: This phase I/II trial is studying the side effects of donor bone marrow transplant and to see how well it works in treating young patients with cancer or a non-cancerous disease.

OBJECTIVES:

Primary

  • Determine the safety and feasibility of filgrastim (G-CSF)-mobilized bone marrow from an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients undergoing allogeneic bone marrow transplantation for malignant or non-malignant disease.

Secondary

  • Determine the time to neutrophil and platelet engraftment, number of red blood cell and platelet transfusions, number of febrile days, and number of hospitalization days in patients treated with this regimen.
  • Determine the number of nucleated cells and CD34-positive cells, absolute lymphocyte count, and lymphocyte subsets (CD3/CD4/CD8) in G-CSF-mobilized bone marrow from these donors.

OUTLINE: This is a multicenter, pilot study.

Donors receive filgrastim (G-CSF) subcutaneously once daily on days -4 to 0. Donors then undergo standard bone marrow harvest on day 0.

Patients receive pre-transplantation conditioning and graft-versus-host disease prophylaxis according to the disease for which the patient is being treated and the treatment plan or clinical trial for which the patient is enrolled on. Patients undergo allogeneic bone marrow transplantation on day 0.

After completion of bone marrow harvest, donors are followed at 7 and 30 days. After completion of study treatment, patients are followed for 100 days post-transplantation and then periodically thereafter.

PROJECTED ACCRUAL: A total of 80 participants (40 donors and 40 patients) will be accrued for this study within 18 months.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Sarcoma
  • Biological: filgrastim
  • Procedure: allogeneic bone marrow transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2007
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DISEASE CHARACTERISTICS:

  • Patients (recipients):

    • Undergoing a myeloablative or nonmyeloablative allogeneic bone marrow transplantation for 1 of the following diseases:

      • Hematologic malignancy
      • Non-hematologic malignancy
      • Non-malignant disease
    • Not undergoing T-cell depleted bone marrow transplantation
  • Donors:

    • Healthy sibling of a patient meeting eligibility requirements for this protocol
    • HLA-identically matched with patient

PATIENT CHARACTERISTICS:

Age

  • 18 and under (patient and donor)

Performance status

  • Karnofsky 90-100% (donor) OR
  • Lansky 90-100% (donor)

Life expectancy

  • Not specified

Hematopoietic

  • No sickle cell anemia (donor)

Hepatic

  • Not specified

Renal

  • Not specified

Immunologic

  • HIV negative (patient and donor)
  • No uncontrolled bacterial, viral, fungal, or parasitic infection (donor)
  • No potentially life threatening autoimmune disease (donor)

Other

  • Not pregnant or nursing (patient and donor)
  • Fertile patients must use effective contraception (patient)
  • No other illness that would severely limit life expectancy (patient)
  • No pre-existing medical condition that would confer a high risk for bone marrow donation (donor)
  • No medical condition or psychiatric trait that would preclude G-CSF administration or bone marrow harvesting (donor)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 years since prior allogeneic blood transfusion (donor)
  • No concurrent growth factors post-transplantation (donor)

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Concurrent participation in another treatment clinical trial allowed provided the use of filgrastim (G-CSF)-mobilized bone marrow is not excluded (patient)
  • No other concurrent investigational agents (donor)
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118326
1802.00, FHCRC-1802.00, PBMTC-STC0233, CDR0000430709
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Fred Hutchinson Cancer Research Center
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Principal Investigator: Ann E. Woolfrey, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
May 2010

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