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Status:

COMPLETED

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

Lead Sponsor:

Fred Hutchinson Cancer Center

Conditions:

Kidney Cancer

Leukemia

Eligibility:

All Genders

Up to 18 years

Phase:

PHASE1

PHASE2

Brief Summary

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-...

Detailed Description

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 unde...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    August 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    May 1 2007

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00118326

    Start Date

    August 1 2003

    End Date

    May 1 2007

    Last Update

    May 14 2010

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, United States, 37232-6838

    2

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024