search
Back to results

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

Primary Purpose

Kidney Cancer, Leukemia, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
filgrastim
allogeneic bone marrow transplantation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring 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

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vanderbilt-Ingram Cancer Center
  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Safety and feasibility

Secondary Outcome Measures

Full Information

First Posted
July 8, 2005
Last Updated
May 12, 2010
Sponsor
Fred Hutchinson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00118326
Brief Title
Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease
Official Title
Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

5. Study Description

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-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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Leukemia, Lymphoma, Myelodysplastic Syndromes, Neuroblastoma, Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Primary Outcome Measure Information:
Title
Safety and feasibility

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann E. Woolfrey, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs