Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Pulmonary Complications; Long-term Effects Secondary to Cancer Therapy in Children

Treatments: Procedure: management of therapy complications

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00009711

1097.00

FHCRC-1097.00

NCI-G00-1911

CDR0000065808 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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