Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00009711

Purpose

RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment.

PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.

Condition	Intervention
Cancer-Related Problem/Condition	Procedure: management of therapy complications

MedlinePlus related topics: Bone Marrow Transplantation Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	280
Study Start Date:	March 1996

Detailed Description:

OBJECTIVES:

Determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy.
Determine the relationship between pulmonary function and growth rates in these patients.
Determine the effect of growth hormone treatment on pulmonary function in these patients.
Determine the relationship between pulmonary function and age at time of transplantation in these patients.
Determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients.

OUTLINE: Patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (PFT) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement.

Patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. Patients with abnormal PFTs are assessed at more frequent intervals as clinically indicated.

PROJECTED ACCRUAL: Approximately 280 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Patients who have undergone bone marrow transplantation for hematologic malignancy at least 5 years ago
- Disease-free survivors at least 6 years of age AND
- Under 18 years of age at time of transplantation
Received prior allogeneic, unrelated donor, syngeneic, or autologous bone marrow transplantation
Able to perform pulmonary function tests

PATIENT CHARACTERISTICS:

Age:

See Disease Characteristics

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

Any prior preparative regimen allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009711

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jean E. Sanders, MD

Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000065808, FHCRC-1097.00, NCI-G00-1911
Study First Received:	February 2, 2001
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00009711
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

long-term effects secondary to cancer therapy in children
pulmonary complications

Study placed in the following topic categories:

Neoplasm Metastasis

ClinicalTrials.gov processed this record on January 16, 2009