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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


Phase 1/Phase 2
N/A
18 Years
Not Enrolling
Both
Kidney Cancer, Leukemia, Lymphoma, Myelodysplastic Syndromes, Neuroblastoma, Sarcoma

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Safety and feasibility

Safety Issue:

Yes

Principal Investigator

Ann E. Woolfrey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1802.00

NCT ID:

NCT00118326

Start Date:

August 2003

Completion Date:

May 2007

Related Keywords:

  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Sarcoma
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neuroblastoma
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838