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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant

Conditions
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Kidney Cancer, Leukemia, Lymphoma, Myelodysplastic Syndromes, Neuroblastoma, Sarcoma

Intervention / Treatment
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* Biological: filgrastim
* Procedure: allogeneic bone marrow transplantation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Procedure: allogeneic bone marrow transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and feasibility |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de novo myelodysplastic syndromes, disseminated neuroblastoma, previously treated myelodysplastic syndromes, recurrent neuroblastoma, secondary myelodysplastic syndromes, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, childhood chronic myelogenous leukemia, juvenile myelomonocytic leukemia, previously treated childhood rhabdomyosarcoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent/refractory childhood Hodgkin lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood rhabdomyosarcoma, recurrent childhood small noncleaved cell lymphoma, untreated childhood acute lymphoblastic leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies