NCT00328029

Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population

Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Signs and Symptoms, Respiratory

Interventions

Type	Name	Description
DRUG	busulfan	5mg/kg/day (oral route : 4 doses/day for 4 days)
PROCEDURE	respiratory function tests	respiratory function tests before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
PROCEDURE	pharmacokinetics, done during the treatment	12 blood collections : * after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h. * 3 hours after 2nd taken of Busulfan * 3 hours after 3rd taken of Busulfan * 3 hours after 4th taken of Busulfan * 3 hours after 5th taken of Busulfan * 3 hours after 6th taken of Busulfan.

Timeline

• Start date: 2006-07-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2006-05-19
• Last updated: 2009-02-25

Locations

2 sites across 1 country: France