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.

Condition	Intervention	Phase
Wilms'''' tumor and other childhood kidney tumors childhood Hodgkin''''s lymphoma childhood non-Hodgkin''''s lymphoma childhood rhabdomyosarcoma Leukemia Neuroblastoma	Drug: filgrastim  Procedure: allogeneic bone marrow transplantation  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: bone marrow transplantation  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy	Phase I Phase II

Further Study Details: 

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.

Ages Eligible for Study:  up to  18 Years,  Genders Eligible for Study:  Both

Criteria

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00118326

Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6310,  United States; Recruiting
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting

Study chairs or principal investigators

Eneida Nemecek, MD,  Principal Investigator,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000430709; FHCRC-1802.00; PBMTC-STC0233; NCT00118326
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 8, 2005
ClinicalTrials.gov Identifier:  NCT00118326
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26