Clinical trial NCT00328029: Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population
Official title: Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Signs and Symptoms, Respiratory
Keywords: Busulfan
pharmacokinetic
respiratory function assessment
Busulfan pharmacokinetic and respiratory function tests
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients above 3 years old treated by busulfan or TBI in their conditioning regimens before allograft or busulfan in high dose chemotherapeutic regimens followed by autograft will be included after parents informed assent.

Primary outcomes:
measure: Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan
timeFrame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
Secondary outcomes:
measure: Comparison to respiratory side effect frequency with TBI conditioning regimen
timeFrame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
measure: Busulfan pharmacokinetics
timeFrame: after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h ; 3 h after 2nd Busulfan taken ; 3 hours after 3rd Busulfan taken ; 3 h after 4st Busulfan taken ;3 h after 5st Busulfan taken ;3 h after 6st Busulfan taken
measure: Establish a potential link between respiratory side effects and busulfan pharmacokinetics
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil
city: Strasbourg
country: France
facility: Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
Study officials:
affiliation: Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
name: Patrick Lutz, MD
role: STUDY_DIRECTOR
References: