Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population
Summary
Recently, several conditioning regimens did not include total body irradiation (TBI) anymore, especially in the case of young children due to cognitive sequelae and late effects on growth and height. Thus, such effective chemotherapy conditioning regimens were developed to avoid these complications. Busulfan is one of the major drugs used in these treatments, but, is also administered in high dose chemotherapy followed by autograft. In both situations, long term pulmonary side effects were diagnosed in a few cases. Even if the occurrence is not very frequent, the clinical management is a real challenge regarding the reduced quality of life and life expectancy of these patients. Up to now, no correlation was done between respiratory sequelae and busulfan pharmacokinetics. Hence, in the investigators' pediatric onco-hematological unit, a prospective study will begin and last three years to assess the respiratory side effects due to busulfan and their potential links with individual drug pharmacokinetic measures. These results will be compared to patients treated with TBI during the same period of time.
Study Design
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Signs and Symptoms, Respiratory
Intervention
busulfan, respiratory function tests, pharmacokinetics, done during the treatment
Location
Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
Strasbourg
France
67098
Status
Recruiting
Source
University Hospital, Strasbourg, France
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00328029
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:43:40-0400
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Medical and Biotech [MESH] Definitions
Diagnostic Techniques, Respiratory System
Methods and procedures for the diagnosis of diseases of the respiratory tract or its organs. It includes RESPIRATORY FUNCTION TESTS.
Busulfan
An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.
Bronchial Provocation Tests
Tests involving inhalation of allergens (nebulized or in dust form), nebulized pharmacologically active solutions (e.g., histamine, methacholine), or control solutions, followed by assessment of respiratory function. These tests are used in the diagnosis of asthma.
Respiratory Function Tests
Measurement of the various processes involved in the act of respiration: inspiration, expiration, oxygen and carbon dioxide exchange, lung volume and compliance, etc.
Vestibular Function Tests
A number of tests used to determine if the brain or balance portion of the inner ear are causing dizziness.
