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

NCT00118326 | Completed Phase 1

• 4 other identifiers: 1802.00FHCRC-1802.00PBMTC-STC0233CDR0000430709
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility

Interventions

filgrastim BIOLOGICAL

allogeneic bone marrow transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Leukemia; Lymphoma; Myelodysplastic Syndromes; Neuroblastoma; Sarcoma; Leukemia, Myelomonocytic, Juvenile; Wilms Tumor; Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dendritic Cell Sarcoma, Interdigitating; Burkitt Lymphoma

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Histiocytic Disorders, Malignant; Histiocytosis; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ann E. Woolfrey, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: August 1, 2003
• Study Completion: May 1, 2007
• Last Updated: May 14, 2010

Record last verified: 2010-05

Locations

US (2)