Clinical trial NCT00009711: Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
Official title: The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long-term Effects Secondary to Cancer Therapy in Children
Pulmonary Complications
Keywords: long-term effects secondary to cancer therapy in children
pulmonary complications
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 280
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Jean E. Sanders, MD
role: STUDY_CHAIR
References: